The Tracker // April 2026
April 2026: 318 FDA device decisions
317 510(k) clearances and 1 original PMA approvals with a decision date in April 2026. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Apr 30, 26 | DEN250023510(k) | Aurie System | Cathbuddy, Inc. | Gastroenterology, Urology | SHV |
| Apr 30, 26 | K250680510(k) | Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. | General Hospital | SAK |
| Apr 30, 26 | K251583510(k) | Ambu® Virobac II® Exhalation Filter | Ambu A/S | Anesthesiology | CAH |
| Apr 30, 26 | K252455510(k) | FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. | Ophthalmic | QQJ |
| Apr 30, 26 | K252503510(k) | Intelligent NR | Canon, Inc. | Radiology | OWB |
| Apr 30, 26 | K252849510(k) | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | Anesthesiology | BYI |
| Apr 30, 26 | K252858510(k) | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | Gastroenterology, Urology | GCJ |
| Apr 30, 26 | K253017510(k) | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | Unknown | QSY |
| Apr 30, 26 | K253064510(k) | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) | Xiamen Weiyou Intelligent Technology Co., Ltd. | Physical Medicine | IRP |
| Apr 30, 26 | K253436510(k) | c-med0 alpha | Cosinuss GmbH | Cardiovascular | MWI |
| Apr 30, 26 | K253976510(k) | iLet ACE Pump | Beta Bionics, Inc. | Clinical Chemistry | QFG |
| Apr 30, 26 | K254189510(k) | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | Radiology | QIH |
| Apr 30, 26 | K260323510(k) | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | Orthopedic | HRS |
| Apr 30, 26 | K260342510(k) | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | Microbiology | GTY |
| Apr 30, 26 | K261067510(k) | BEE PLIF Cage | NGMedical GmbH | Orthopedic | MAX |
| Apr 30, 26 | K261404510(k) | UltraEZ | Ultradent Products, Inc. | Dental | LBH |
| Apr 29, 26 | K252471510(k) | Paptizer 360 | LiViliti Health Products Corporation | General Hospital | QXQ |
| Apr 29, 26 | K252542510(k) | LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | Orthopedic | NKB |
| Apr 29, 26 | K253166510(k) | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | Anesthesiology | BZD |
| Apr 29, 26 | K253401510(k) | SCRIPT Implant System | Globus Medical, Inc. | Orthopedic | OVD |
| Apr 29, 26 | K253579510(k) | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, Inc. | Cardiovascular | MOF |
| Apr 29, 26 | K253682510(k) | DeepHealth ProstateAI | Quantib B.V. | Radiology | QDQ |
| Apr 29, 26 | K253885510(k) | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES | GEO MEDICAL CO., LTD. | Ophthalmic | LPL |
| Apr 29, 26 | K253914510(k) | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Apr 29, 26 | K254184510(k) | syngo Application Software | Siemens Medical Solutions USA, Inc. | Radiology | QIH |
| Apr 29, 26 | K260589510(k) | ES-Series | E-Scopics | Radiology | IYN |
| Apr 29, 26 | K260606510(k) | Echo Large Bore Introducer Sheath | Echo Medical, LLC | Cardiovascular | DYB |
| Apr 29, 26 | K261086510(k) | Break Wave | Sonomotion, Inc. | Gastroenterology, Urology | LNS |
| Apr 29, 26 | K261094510(k) | YellowStar | Asclepion Laser Technologies GmbH | General, Plastic Surgery | GEX |
| Apr 28, 26 | K252424510(k) | Anti-HCV Next | Abbott Laboratories | Microbiology | MZO |
| Apr 28, 26 | K252464510(k) | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | Dental | NBL |
| Apr 28, 26 | K252501510(k) | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | Joytech Healthcare Co. , Ltd. | Cardiovascular | DXN |
| Apr 28, 26 | K252831510(k) | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) | Dolanvy (Suzhou) Medical Technology Co., Ltd. | Gastroenterology, Urology | KPI |
| Apr 28, 26 | K253243510(k) | Cardinal Health Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | General, Plastic Surgery | FYA |
| Apr 28, 26 | K253940510(k) | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | Orthopedic | NKB |
| Apr 28, 26 | K260065510(k) | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx | Guangzhou Wondfo Biotech Co., Ltd. | Clinical Toxicology | NFT |
| Apr 28, 26 | K260076510(k) | SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC | Physical Medicine | PFW |
| Apr 28, 26 | K260121510(k) | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | Physical Medicine | IOR |
| Apr 28, 26 | K260194510(k) | Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited | Obstetrics/Gynecology | MQG |
| Apr 28, 26 | K260248510(k) | Ultra-Fast Warm | Kitazato Corporation | Obstetrics/Gynecology | MQL |
| Apr 28, 26 | K260260510(k) | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. | Cardiovascular | DXN |
| Apr 27, 26 | K252409510(k) | TearCare MGX System | Sight Sciences, Inc. | Ophthalmic | ORZ |
| Apr 27, 26 | K252445510(k) | Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | Cardiovascular | DSY |
| Apr 27, 26 | K252628510(k) | CASSIE | Wesper, Inc. | Anesthesiology | MNR |
| Apr 27, 26 | K252748510(k) | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | Obstetrics/Gynecology | HIR |
| Apr 27, 26 | K253658510(k) | STA Satellite Max® | Diagnostica Stago, Inc. | Hematology | JPA |
| Apr 27, 26 | K260182510(k) | Avenir® Müller Stem; Avenir Complete Hip System | Zimmer, Inc. | Orthopedic | LZO |
| Apr 27, 26 | K260660510(k) | SABER-C System | Elevation Spine | Orthopedic | OVE |
| Apr 27, 26 | K261032510(k) | NovoKnee (SteriKnee) | NovoSource | Orthopedic | JWH |
| Apr 27, 26 | K261356510(k) | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | Dental | EBF |
| Apr 27, 26 | K261357510(k) | Grandio disc multicolor | Voco GmbH | Dental | EBF |
| Apr 26, 26 | K253580510(k) | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | Tedan Surgical Innovations | Ear, Nose, Throat | PDQ |
| Apr 24, 26 | K250234510(k) | SMARTeZ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | General Hospital | MEB |
| Apr 24, 26 | K250242510(k) | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | Cardiovascular | JOW |
| Apr 24, 26 | K250349510(k) | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | Cardiovascular | MHX |
| Apr 24, 26 | K252336510(k) | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | Diazyme Laboratories, Inc. | Unknown | |
| Apr 24, 26 | K252337510(k) | EdgeFlow Gel Pad | Edgecare, Inc. | Radiology | MUI |
| Apr 24, 26 | K252431510(k) | Elecsys Calcitonin | Roche Diagnostics GmbH | Clinical Chemistry | JKR |
| Apr 24, 26 | K252451510(k) | EPORE® XO cup system | Implantcast GmbH | Orthopedic | OQI |
| Apr 24, 26 | K252492510(k) | Visualized Access and Delivery Catheter; PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | Gastroenterology, Urology | SHU |
| Apr 24, 26 | K252810510(k) | FloPatch FP120 | Flosonics Medical | Cardiovascular | DPW |
| Apr 24, 26 | K253459510(k) | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | ABBOTT MEDICAL | Radiology | NQQ |
| Apr 24, 26 | K253805510(k) | Knee+ | Pixee Medical S.A.S. | Neurology | SBF |
| Apr 24, 26 | K253832510(k) | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | Gastroenterology, Urology | FGE |
| Apr 24, 26 | K254173510(k) | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. | Radiology | OWB |
| Apr 24, 26 | K260009510(k) | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | Radiology | LLZ |
| Apr 24, 26 | K260054510(k) | I.T.S. PRS Phoenix II | I.T.S. GmbH | Orthopedic | HRS |
| Apr 24, 26 | K260228510(k) | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | Orthopedic | HRS |
| Apr 24, 26 | K260411510(k) | PC Fix System | Chest Wall Innovations, Inc. | Orthopedic | HRS |
| Apr 24, 26 | K260429510(k) | Control-IQ+ technology | Tandem Diabetes Care, Inc. | Clinical Chemistry | QJI |
| Apr 24, 26 | K260549510(k) | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | Orthopedic | ODP |
| Apr 24, 26 | K260599510(k) | INDIGO® Aspiration System INDIGO Link | Penumbra, Inc. | Cardiovascular | QEW |
| Apr 24, 26 | K260982510(k) | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) | Applied Medical Resources Corporation | General, Plastic Surgery | KGW |
| Apr 24, 26 | K260988510(k) | °M Warmer System with °M Station | Mequ A/S | General Hospital | LGZ |
| Apr 24, 26 | K260993510(k) | Amplatzer TorqVue Delivery System | Abbott | Cardiovascular | DQY |
| Apr 24, 26 | K260999510(k) | LoFric Elle Pro | Wellspect AB | Gastroenterology, Urology | EZD |
| Apr 24, 26 | K261008510(k) | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute | Stryker Spine | Orthopedic | MQV |
| Apr 24, 26 | K261043510(k) | AUTOBAHN Nailing System | Globus Medical, Inc. | Orthopedic | HSB |
| Apr 23, 26 | K252341510(k) | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | Olympus Medical Systems Corp. | Ear, Nose, Throat | EOQ |
| Apr 23, 26 | K252389510(k) | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | Cardiovascular | DSH |
| Apr 23, 26 | K252407510(k) | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | Anesthesiology | CAW |
| Apr 23, 26 | K252436510(k) | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | Ear, Nose, Throat | ETD |
| Apr 23, 26 | K252815510(k) | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | Radiology | LHN |
| Apr 23, 26 | K253589510(k) | Liberant RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. | Cardiovascular | QEZ |
| Apr 23, 26 | K253752510(k) | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | Radiology | OWB |
| Apr 23, 26 | K254237510(k) | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | Radiology | LLZ |
| Apr 23, 26 | K254248510(k) | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | Cardiovascular | DYB |
| Apr 23, 26 | K260152510(k) | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | Dental | EBF |
| Apr 23, 26 | K260195510(k) | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | Medtronic, Inc. | Cardiovascular | DWF |
| Apr 23, 26 | K260320510(k) | Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. | Radiology | QDQ |
| Apr 23, 26 | K260785510(k) | DS Core CBCT Anatomy | Dentsply Sirona | Radiology | QIH |
| Apr 23, 26 | K260947510(k) | 0.55T 12Ch Breast Coil | Neocoil, LLC | Radiology | MOS |
| Apr 23, 26 | K260976510(k) | NeuroBlate System | Monteris Medical | General, Plastic Surgery | ONO |
| Apr 23, 26 | K261012510(k) | OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. | Cardiovascular | MTD |
| Apr 22, 26 | K252306510(k) | Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100) | Steritec Products | General Hospital | QVB |
| Apr 22, 26 | K253077510(k) | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | QIH |
| Apr 22, 26 | K253163510(k) | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | Ever Fortune.Ai, Co., Ltd. | Radiology | QAS |
| Apr 22, 26 | K253230510(k) | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Erbe Elektromedizin GmbH | General, Plastic Surgery | GEH |
| Apr 22, 26 | K253256510(k) | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | Neurology | GXY |
| Apr 22, 26 | K253765510(k) | VANISH PRO | Ddc Technologies, Inc. | General, Plastic Surgery | GEX |
| Apr 22, 26 | K260150510(k) | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | NOOANCE | General, Plastic Surgery | OHS |
| Apr 22, 26 | K260237510(k) | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | Physical Medicine | INI |
| Apr 22, 26 | K260239510(k) | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | Obstetrics/Gynecology | HGX |
| Apr 22, 26 | K260570510(k) | corra cervical plating system | Carlsmed, Inc. | Orthopedic | KWQ |
| Apr 21, 26 | K250793510(k) | RhythmStar System (SL) | RhythMedix, LLC | Cardiovascular | QYX |
| Apr 21, 26 | K253982510(k) | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | Cardiovascular | DXN |
| Apr 21, 26 | K254046510(k) | BosCATH Support Catheter | Sonorous NV, Inc. | Cardiovascular | QJP |
| Apr 21, 26 | K260216510(k) | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | Medtronic Sofamor Danek USA, Inc. | Orthopedic | NKB |
| Apr 21, 26 | K260447510(k) | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | Microbiology | JWY |
| Apr 21, 26 | K260518510(k) | IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | General, Plastic Surgery | OHT |
| Apr 21, 26 | K260573510(k) | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | Gastroenterology, Urology | FDS |
| Apr 21, 26 | K260921510(k) | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | Orthopedic | MBI |
| Apr 20, 26 | K242163510(k) | SmartSurgN Visualization System | SmartsurgN, Inc. | Gastroenterology, Urology | OWN |
| Apr 20, 26 | K252332510(k) | Folliscan | Mim Fertility | Radiology | QIH |
| Apr 20, 26 | K252718510(k) | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Radiology | KGI |
| Apr 20, 26 | K253003510(k) | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | Hubei Xinxin Non-Woven Co., Ltd. | General, Plastic Surgery | FYA |
| Apr 20, 26 | K253213510(k) | SAGI Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | Orthopedic | OVE |
| Apr 20, 26 | K253558510(k) | Luminoah FLOW Enteral Nutrition System | Luminoah | General Hospital | LZH |
| Apr 20, 26 | K253638510(k) | xStep (xStep) | Spinex, Inc. | Physical Medicine | SDO |
| Apr 20, 26 | K253806510(k) | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Physical Medicine | ITI |
| Apr 20, 26 | K260153510(k) | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | General, Plastic Surgery | GEX |
| Apr 20, 26 | K260212510(k) | EnSite X EP System | ABBOTT MEDICAL | Cardiovascular | DQK |
| Apr 17, 26 | DEN250033510(k) | XplantR Explant Tool | Hjarta Care, LLC | Cardiovascular | SHR |
| Apr 17, 26 | K252237510(k) | EdgeFlow UW20 | Edgecare, Inc. | Radiology | IYO |
| Apr 17, 26 | K252279510(k) | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | General Hospital | FMF |
| Apr 17, 26 | K252334510(k) | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Pontemedag | Gastroenterology, Urology | KPI |
| Apr 17, 26 | K252338510(k) | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | Anesthesiology | BZD |
| Apr 17, 26 | K252945510(k) | Novasight Hybrid System | Conavi Medical, Inc. | Cardiovascular | OBJ |
| Apr 17, 26 | K253970510(k) | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | Neurology | GZL |
| Apr 17, 26 | K254279510(k) | Edwards eSheath+ introducer set | Edwards Lifesciences | Cardiovascular | DYB |
| Apr 17, 26 | K260696510(k) | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | Microbiology | JWY |
| Apr 17, 26 | K260900510(k) | DYNEX® External Fixation Systems | Vilex, LLC | Orthopedic | KTT |
| Apr 17, 26 | K260929510(k) | Neonav ECG Tip Location System | Navi Medical Technologies | General Hospital | LJS |
| Apr 17, 26 | K260934510(k) | TITAN Nail; APTUS K-Wire System | Medartis AG | Orthopedic | HWC |
| Apr 17, 26 | K261261510(k) | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | Dental | EBG |
| Apr 16, 26 | K251478510(k) | ClearTip TBNA Type | Finemedix Co., Ltd. | Ear, Nose, Throat | KTI |
| Apr 16, 26 | K251658510(k) | Endoflux Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | Gastroenterology, Urology | FGE |
| Apr 16, 26 | K252317510(k) | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | Cardiovascular | MOF |
| Apr 16, 26 | K252318510(k) | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | Obstetrics/Gynecology | HIF |
| Apr 16, 26 | K253048510(k) | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. | Cardiovascular | DXT |
| Apr 16, 26 | K253170510(k) | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Cardiovascular | MHX |
| Apr 16, 26 | K253260510(k) | ORIO-3D Cage System | SpineCraft | Orthopedic | ODP |
| Apr 16, 26 | K253523510(k) | Freedom DS Decompression System | Spinal Simplicity | Orthopedic | HRX |
| Apr 16, 26 | K253537510(k) | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) | Bright Uro, Inc. | Gastroenterology, Urology | EXQ |
| Apr 16, 26 | K253804510(k) | DESS Dental Smart Solutions | Terrats Medical SL | Dental | NHA |
| Apr 16, 26 | K253892510(k) | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, | Strauss Surgical USA | Gastroenterology, Urology | FAJ |
| Apr 16, 26 | K253907510(k) | Disposable Radiofrequency Cannula | ABBOTT MEDICAL | Neurology | GXI |
| Apr 16, 26 | K254101510(k) | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | Obstetrics/Gynecology | NUC |
| Apr 16, 26 | K254216510(k) | Enso for Migraine | Hinge Health, Inc. | Neurology | PCC |
| Apr 16, 26 | K254223510(k) | Next Generation 088 Catheter | Balt USA, LLC | Cardiovascular | QJP |
| Apr 16, 26 | K254273510(k) | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | General Hospital | FMI |
| Apr 16, 26 | K254274510(k) | ARx® SAI Implant System | Life Spine, Inc. | Orthopedic | NKB |
| Apr 16, 26 | K260011510(k) | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | Neurology | OLO |
| Apr 16, 26 | K260020510(k) | Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. | Unknown | QSZ |
| Apr 16, 26 | K260903510(k) | Hot Pink Pad Warming System | Xodus Medical, Inc. | Cardiovascular | DWJ |
| Apr 15, 26 | K252258510(k) | VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | Radiology | IYE |
| Apr 15, 26 | K252404510(k) | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | Orthopedic | PHX |
| Apr 15, 26 | K252728510(k) | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | Clinical Chemistry | CDZ |
| Apr 15, 26 | K252774510(k) | Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | Orthopedic | OVE |
| Apr 15, 26 | K252843510(k) | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. | General Hospital | MLR |
| Apr 15, 26 | K253337510(k) | REGEN Bioactive Cement | Inter-Med, Inc. | Dental | EMA |
| Apr 15, 26 | K253573510(k) | ASTar BC G- Kit | Q-Linea AB | Microbiology | SAN |
| Apr 15, 26 | K254107510(k) | Refobacin Bone Cement R (110034355) | Biomet France | Orthopedic | LOD |
| Apr 15, 26 | K260128510(k) | BD Preset and BD A-Line Arterial Blood Collection Syringes | Becton, Dickinson and Company | Clinical Chemistry | JKA |
| Apr 15, 26 | K260129510(k) | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | General, Plastic Surgery | OLI |
| Apr 15, 26 | K260282510(k) | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | Microbiology | LON |
| Apr 15, 26 | K260307510(k) | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | General, Plastic Surgery | GEX |
| Apr 15, 26 | K260661510(k) | Midas Restore | Sprintray, Inc. | Dental | EBF |
| Apr 15, 26 | K260722510(k) | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | Dental | NXC |
| Apr 15, 26 | K260938510(k) | PATH BGC | Crossroads Neurovascular, Inc. | Cardiovascular | QJP |
| Apr 14, 26 | K240974510(k) | SPRINT PNS System | Spr Therapeutics, Inc. | Neurology | SCN |
| Apr 14, 26 | K252587510(k) | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | Radiology | MOS |
| Apr 14, 26 | K252663510(k) | Inbentus Versatile | Iconic Solutions by Murcia, SL | Anesthesiology | CBK |
| Apr 14, 26 | K253107510(k) | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | Shenzhen Dongjiang Technology Co., Ltd. | General, Plastic Surgery | BTA |
| Apr 14, 26 | K253502510(k) | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC | Radiology | QIH |
| Apr 14, 26 | K260498510(k) | TriMemo SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | Cardiovascular | KRH |
| Apr 14, 26 | K260583510(k) | Equinoxe® Shoulder System | Exactech, Inc. | Orthopedic | PHX |
| Apr 14, 26 | K260931510(k) | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | Cardiovascular | DQA |
| Apr 13, 26 | K252280510(k) | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | Microbiology | QVP |
| Apr 13, 26 | K253357510(k) | b-ONE® Bipolar Head | B-One Ortho, Corp. | Orthopedic | KWY |
| Apr 13, 26 | K253592510(k) | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer, Inc. | Orthopedic | MBF |
| Apr 13, 26 | K253861510(k) | ACORYS MAPPING SYSTEM | Corify Care S.L | Cardiovascular | DQK |
| Apr 13, 26 | K254078510(k) | HVT 2.0 | Vapotherm, Inc. | Anesthesiology | BTT |
| Apr 13, 26 | K254128510(k) | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | Orthopedic | PHX |
| Apr 13, 26 | K260091510(k) | Aventus Introducer Sheath | Inquis Medical | Cardiovascular | DYB |
| Apr 13, 26 | K260095510(k) | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC | Microbiology | QYT |
| Apr 13, 26 | K260340510(k) | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | Orthopedic | ODP |
| Apr 13, 26 | K260965510(k) | CVAC Aspiration System | Calyxo, Inc. | Gastroenterology, Urology | FED |
| Apr 10, 26 | K252190510(k) | DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. | Radiology | QKB |
| Apr 10, 26 | K252207510(k) | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | Clinical Chemistry | CHL |
| Apr 10, 26 | K252241510(k) | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | Neurology | GWM |
| Apr 10, 26 | K252250510(k) | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) | Shanghai Draeger Medical Instrument Co., Ltd. | Cardiovascular | MHX |
| Apr 10, 26 | K252378510(k) | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | Becton, Dickinson and Company | Clinical Chemistry | JKA |
| Apr 10, 26 | K252485510(k) | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) | 1987 Media Limited | Unknown | OBR |
| Apr 10, 26 | K252506510(k) | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | Clinical Chemistry | JKA |
| Apr 10, 26 | K252548510(k) | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | Radiology | QKB |
| Apr 10, 26 | K252699510(k) | CoAptix S System | University of Utah, Department of Orthopaedics | Orthopedic | HWC |
| Apr 10, 26 | K252708510(k) | Relu Cloud | Relu BV | Radiology | QIH |
| Apr 10, 26 | K252757510(k) | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | General Hospital | OPP |
| Apr 10, 26 | K252942510(k) | ShaeferH | Shaeferh, LLC | Dental | LRK |
| Apr 10, 26 | K253361510(k) | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Cardiovascular | DQY |
| Apr 10, 26 | K253446510(k) | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | Radiology | KPR |
| Apr 10, 26 | K253510510(k) | Freestyle Mini Hands-free | Medela, LLC | Obstetrics/Gynecology | HGX |
| Apr 10, 26 | K253657510(k) | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads | Covidien (Part of Medtronic) | General, Plastic Surgery | GDW |
| Apr 10, 26 | K253689510(k) | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | Radiology | QIH |
| Apr 10, 26 | K253777510(k) | Ascblue (8010) | Ascblue Corporation | General, Plastic Surgery | GEI |
| Apr 10, 26 | K253917510(k) | ARION ARC System | Plasma Surgical, Inc. | General, Plastic Surgery | GEI |
| Apr 10, 26 | K253926510(k) | Diacore | ShenB Co., Ltd. | Physical Medicine | NGX |
| Apr 10, 26 | K253930510(k) | Overjet Iris Intelligent Imaging System | Overjet, Inc. | Radiology | QIH |
| Apr 10, 26 | K254004510(k) | VRNT | Cognifisense, Inc. | Neurology | QRA |
| Apr 10, 26 | K260082510(k) | TRIOS Dx (R1) | 3Shape TRIOS A/S | Dental | SHQ |
| Apr 10, 26 | K260090510(k) | SMART Osteotomy System | Actis Medical Pty., Ltd. | Orthopedic | HRS |
| Apr 10, 26 | K260244510(k) | Auryon Atherectomy System | Eximo Medical | Cardiovascular | MCW |
| Apr 10, 26 | K260430510(k) | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | Dental | KLE |
| Apr 10, 26 | K260508510(k) | LOBO Vascular Occlusion System | Okami Medical, Inc. | Cardiovascular | KRD |
| Apr 10, 26 | K260839510(k) | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | Cardiovascular | DYB |
| Apr 9, 26 | K252228510(k) | Seaman Pro/Seaman | Checkcells, Inc. | Hematology | POV |
| Apr 9, 26 | K252251510(k) | EASYMADE-TI | CG Bio Co., Ltd. | Neurology | GXN |
| Apr 9, 26 | K252929510(k) | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) | Anhui Happiness Workshop Instruments Co., Ltd. | Gastroenterology, Urology | FGB |
| Apr 9, 26 | K253975510(k) | Radical 6F Access Catheter | Maduro Medical, Inc. | Cardiovascular | QJP |
| Apr 9, 26 | K254021510(k) | Accuro XV | Rivanna Medical, Inc. | Radiology | IYO |
| Apr 9, 26 | K254158510(k) | SPINEART Navigation Instrument System | Spineart SA | Neurology | OLO |
| Apr 9, 26 | K260017510(k) | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Apr 9, 26 | K260067510(k) | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | Dental | EIH |
| Apr 9, 26 | K260245510(k) | SILKBridge | KLISBio S.r.l. | Neurology | JXI |
| Apr 9, 26 | K260317510(k) | Artelon Convenience Kits | International Life Sciences | General, Plastic Surgery | QWJ |
| Apr 9, 26 | K260462510(k) | RCT800 | Ray Co., Ltd. | Radiology | OAS |
| Apr 9, 26 | K260555510(k) | LOCATOR® Angled Abutment | Zest Anchors, LLC | Dental | NHA |
| Apr 8, 26 | K251666510(k) | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | General Hospital | MED |
| Apr 8, 26 | K251889510(k) | myAir | Resmed Corp | Anesthesiology | MNS |
| Apr 8, 26 | K252224510(k) | Apex Locator (FindPex) | Changzhou Sifary Medical Technology Co., Ltd. | Unknown | LQY |
| Apr 8, 26 | K252270510(k) | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | Gastroenterology, Urology | PKL |
| Apr 8, 26 | K253268510(k) | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | CMT Health PTE., Ltd. | Gastroenterology, Urology | PNR |
| Apr 8, 26 | K253534510(k) | Pivot Insulin Delivery System | Modular Medical | General Hospital | LZG |
| Apr 8, 26 | K254258510(k) | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Apr 8, 26 | K260033510(k) | Wearable Breast Pump (Model S21A) | Shenzhen TPH Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Apr 8, 26 | K260089510(k) | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | Gastroenterology, Urology | GCJ |
| Apr 8, 26 | K260197510(k) | Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | Gastroenterology, Urology | GCJ |
| Apr 8, 26 | K260420510(k) | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | MacroLux Medical Technology Co., Ltd. | Ear, Nose, Throat | EOQ |
| Apr 8, 26 | K260477510(k) | CATAMARAN SI Joint Fusion System | Tenon Medical | Orthopedic | OUR |
| Apr 8, 26 | K260766510(k) | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | General Hospital | FRC |
| Apr 8, 26 | K260816510(k) | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | Boston Scientific | Cardiovascular | OBJ |
| Apr 7, 26 | K252116510(k) | Firefighter Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | Cardiovascular | LOX |
| Apr 7, 26 | K252861510(k) | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | Cardiovascular | DWJ |
| Apr 7, 26 | K252979510(k) | Voyager DSLT (430840610) | Belkin Vision, Ltd. | Ophthalmic | HQF |
| Apr 7, 26 | K253801510(k) | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. | Cardiovascular | SHP |
| Apr 7, 26 | K253905510(k) | PrimeSight UltraView System | Cogentix Medical, Inc. | Gastroenterology, Urology | FAJ |
| Apr 7, 26 | K253946510(k) | Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Apr 7, 26 | K253952510(k) | Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. | Physical Medicine | ITI |
| Apr 7, 26 | K254191510(k) | IWD-Gel | InnovaCorium, Inc. | Unknown | FRO |
| Apr 7, 26 | K260046510(k) | Elecsys Anti-HBc II | Roche Diagnostics | Microbiology | SEI |
| Apr 7, 26 | K260048510(k) | Elecsys Anti-HAV IgM | Roche Diagnostics | Microbiology | LOL |
| Apr 7, 26 | K260049510(k) | Elecsys Anti-HBc IgM | Roche Diagnostics | Microbiology | SEI |
| Apr 7, 26 | K260466510(k) | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | General, Plastic Surgery | GEI |
| Apr 7, 26 | K260860510(k) | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology, Inc. | General Hospital | LYZ |
| Apr 7, 26 | K260942510(k) | AuST Steerable Sheath | CenterPoint Systems, LLC | Cardiovascular | DYB |
| Apr 6, 26 | K250208510(k) | SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. | Obstetrics/Gynecology | HGX |
| Apr 6, 26 | K252182510(k) | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Anesthesiology | MNT |
| Apr 6, 26 | K252765510(k) | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | Dental | PLC |
| Apr 6, 26 | K252809510(k) | in2 Smart (in2S) | Virility Medical , Ltd. | Gastroenterology, Urology | QRC |
| Apr 6, 26 | K253025510(k) | Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC | Radiology | IXI |
| Apr 6, 26 | K253036510(k) | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | Dental | EBF |
| Apr 6, 26 | K253288510(k) | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | Radiology | IYN |
| Apr 6, 26 | K253862510(k) | APERTO Lucent MRI System | Fujifilm Corporation | Radiology | LNH |
| Apr 6, 26 | K254084510(k) | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | Orthopedic | KWS |
| Apr 6, 26 | K254091510(k) | GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. | Dental | EBD |
| Apr 6, 26 | K260397510(k) | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | General, Plastic Surgery | GEI |
| Apr 6, 26 | K260459510(k) | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | Cardiovascular | DYB |
| Apr 6, 26 | K260521510(k) | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | Zhuhai Pusen Medical Technology Co., Ltd. | Gastroenterology, Urology | FED |
| Apr 3, 26 | DEN240071510(k) | neuropacs | Automated Imaging Diagnostics, LLC | Neurology | SHO |
| Apr 3, 26 | K250074510(k) | HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics, Inc. | Orthopedic | KWD |
| Apr 3, 26 | K252386510(k) | Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd | Physical Medicine | IRP |
| Apr 3, 26 | K252495510(k) | LSSA (NP-200) | Newpong Co., Ltd. | General, Plastic Surgery | QPB |
| Apr 3, 26 | K252744510(k) | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Cixi Ruihong Electric Appliance Co., Ltd. | Obstetrics/Gynecology | HGX |
| Apr 3, 26 | K253042510(k) | Tyber Medical Trauma Screw | Tyber Medical, LLC | Orthopedic | HWC |
| Apr 3, 26 | K253056510(k) | Disposable Stone Extraction Basket | Zhejiang Soudon Medical Technology Co., Ltd. | Gastroenterology, Urology | LQR |
| Apr 3, 26 | K253340510(k) | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | Physical Medicine | ITI |
| Apr 3, 26 | K253674510(k) | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | Orthopedic | PHX |
| Apr 3, 26 | K253962510(k) | ClearCheck (RADCC V2.7) | Radformation, Inc. | Radiology | IYE |
| Apr 3, 26 | K254060510(k) | Life Saving Tourniquet | TW Medical | Cardiovascular | DXC |
| Apr 3, 26 | K254066510(k) | Etiometry Platform | Etiometry, Inc. | Cardiovascular | PPW |
| Apr 3, 26 | K254153510(k) | Single-use Video Scope; PB Digital Controller | Mirco-Tech (Nanjing) Co., Ltd. | Gastroenterology, Urology | FBN |
| Apr 3, 26 | K260363510(k) | Ceribell Brain Monitor Headband | Ceribell, Inc. | Neurology | GXY |
| Apr 3, 26 | K260524510(k) | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS |
| Apr 3, 26 | K260718510(k) | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) | MED-EL Elektromedizinische Geräte GmbH | Ear, Nose, Throat | ETB |
| Apr 3, 26 | K260719510(k) | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | MED-EL Elektromedizinische Geräte GmbH | Ear, Nose, Throat | ETA |
| Apr 3, 26 | K260720510(k) | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); | MED-EL Elektromedizinische Geräte GmbH | Ear, Nose, Throat | ETB |
| Apr 3, 26 | K260724510(k) | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | Gastroenterology, Urology | QNP |
| Apr 3, 26 | K260786510(k) | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | Orthopedic | NKB |
| Apr 2, 26 | K250516510(k) | SMART M-CELL PRP Concentration System | Miracell Co., Ltd. | Clinical Chemistry | QBV |
| Apr 2, 26 | K250518510(k) | SMART M-CELL Bone Marrow Concentration System | Miracell Co., Ltd. | Clinical Chemistry | QBV |
| Apr 2, 26 | K252079510(k) | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | General Hospital | KPE |
| Apr 2, 26 | K252130510(k) | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | General Hospital | PHC |
| Apr 2, 26 | K252137510(k) | BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | General Hospital | FOZ |
| Apr 2, 26 | K252198510(k) | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | General, Plastic Surgery | GEH |
| Apr 2, 26 | K252229510(k) | BELLIGER ACE | Genoray Co., Ltd. | Radiology | OWB |
| Apr 2, 26 | K252246510(k) | Leforte MMF System | Jeil Medical Corporation | Dental | JEY |
| Apr 2, 26 | K252709510(k) | Wireless Probe Type Ultrasound Scanner | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Radiology | IYN |
| Apr 2, 26 | K253076510(k) | Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd | Physical Medicine | IRP |
| Apr 2, 26 | K254022510(k) | FLASH Flex Aorto-Ostial Angioplasty System | Verge Medical, Inc. | Cardiovascular | LOX |
| Apr 2, 26 | K260026510(k) | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | Immunology | NQD |
| Apr 2, 26 | K260184510(k) | Onclarity Self-Collection Kit | Becton, Dickinson and Company | Microbiology | SEP |
| Apr 2, 26 | K260647510(k) | SPECCHIO | El.En S.P.A. | General, Plastic Surgery | PBX |
| Apr 2, 26 | K260796510(k) | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | Orthopedic | HSX |
| Apr 2, 26 | P250033PMA | NEXUS Aortic Arch Stent Graft System | Endospan , Ltd. | Cardiovascular | SDZ |
| Apr 1, 26 | K242303510(k) | MOD-C | Orthomod, LLC | Orthopedic | ODP |
| Apr 1, 26 | K252513510(k) | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) | Poly Medicure Limited | General Hospital | FOZ |
| Apr 1, 26 | K252876510(k) | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only | Shenzhen RF Tech Co., Ltd. | Radiology | MOS |
| Apr 1, 26 | K252943510(k) | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | Convatec Limited | Gastroenterology, Urology | EZD |
| Apr 1, 26 | K253405510(k) | Prana System | Prana Surgical | General, Plastic Surgery | GEI |
| Apr 1, 26 | K253473510(k) | Synchrony | Stereotaxis, Inc. | Cardiovascular | DQK |
| Apr 1, 26 | K253582510(k) | Medical Imaging Calibration Feature (MICF) | Apple, Inc. | Radiology | SHN |
| Apr 1, 26 | K253586510(k) | RM Electrode (RMH 25-01) | Retmap, Inc. | Ophthalmic | HLZ |
| Apr 1, 26 | K253718510(k) | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | Orthopedic | HRS |
| Apr 1, 26 | K254015510(k) | CoLumbo C-Spine | Smart Soft Healthcare AD | Radiology | QIH |
| Apr 1, 26 | K254225510(k) | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen HanHan Technology Co., Ltd. | Cardiovascular | DXN |
| Apr 1, 26 | K260007510(k) | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Hudi Pharma Srl | Obstetrics/Gynecology | NUC |
| Apr 1, 26 | K260276510(k) | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro | Shenzhen AOJ Medical Technology Co., Ltd. | Cardiovascular | DXN |
August 2026
July 2026
June 2026
May 2026
April 2026
March 2026
February 2026
January 2026
December 2025
November 2025
October 2025
September 2025
Source: FDA 510(k) and PMA databases via openFDA. PMA supplements are excluded.