The Tracker // December 2025
December 2025: 301 FDA device decisions
291 510(k) clearances and 10 original PMA approvals with a decision date in December 2025. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Dec 31, 25 | K243627510(k) | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) | Arc Trauma, LLC | Cardiovascular | DXC |
| Dec 31, 25 | K252901510(k) | Tyber Medical Trauma Screw | Tyber Medical, LLC | Orthopedic | HWC |
| Dec 31, 25 | K252951510(k) | Genesis Sleep | Neurofield, Inc. | Neurology | QJQ |
| Dec 31, 25 | K253305510(k) | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | Shenzhen Jiantuo Electronics Co., Ltd. | Neurology | NUH |
| Dec 31, 25 | K253888510(k) | MOLLI 2 System | Stryker Endoscopy | General, Plastic Surgery | NEU |
| Dec 31, 25 | P250010PMA | ProlivRx System | Neurolief , Ltd. | Neurology | JXK |
| Dec 30, 25 | K242492510(k) | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) | Techno-Path Manufacturing , Ltd. | Microbiology | QCH |
| Dec 30, 25 | K250168510(k) | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | General Hospital | FLE |
| Dec 30, 25 | K251091510(k) | Lipids | Truvian Health | Clinical Chemistry | CHH |
| Dec 30, 25 | K253532510(k) | TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. | Radiology | QIH |
| Dec 30, 25 | K253844510(k) | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | Radiology | KPS |
| Dec 30, 25 | K253895510(k) | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. | Orthopedic | MBI |
| Dec 29, 25 | K251025510(k) | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | Covidien, LLC | Anesthesiology | BZT |
| Dec 29, 25 | K251123510(k) | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | Gastroenterology, Urology | FGE |
| Dec 29, 25 | K251313510(k) | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT | Covidien, LLC | Anesthesiology | JOH |
| Dec 29, 25 | K251534510(k) | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | Anesthesiology | CAW |
| Dec 29, 25 | K253325510(k) | ZipToe Hammertoe Fusion System | Toetal Solutions | Orthopedic | HTY |
| Dec 29, 25 | K253343510(k) | Celebrace Software | Celebrace | Dental | PNN |
| Dec 29, 25 | K253881510(k) | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) | Shenzhen Fansizhe Science and Technology Co., Ltd. | General, Plastic Surgery | OHT |
| Dec 24, 25 | K253279510(k) | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | General, Plastic Surgery | OHS |
| Dec 24, 25 | K253342510(k) | PICO-K | Speclipse, Inc. | General, Plastic Surgery | GEX |
| Dec 24, 25 | K253349510(k) | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | Physical Medicine | OAP |
| Dec 24, 25 | K253400510(k) | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) | Shenzhen Saidi Light Therapy Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Dec 23, 25 | DEN250004510(k) | QIKCAP System | Hai Solutions | General Hospital | SGX |
| Dec 23, 25 | DEN250032510(k) | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) | DiaSorin, Inc. | Immunology | SGW |
| Dec 23, 25 | K250476510(k) | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | Dental | DZE |
| Dec 23, 25 | K251268510(k) | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | Edan Instruments, Inc. | Radiology | IYN |
| Dec 23, 25 | K251683510(k) | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) | Bruno Vision Care, LLC | Ophthalmic | LPL |
| Dec 23, 25 | K251800510(k) | Healgen® URS Test Strips | Healgen Scientific,, LLC | Clinical Chemistry | JMT |
| Dec 23, 25 | K251958510(k) | VEINOPLUS Back | Dynapulse Medical | Neurology | NUH |
| Dec 23, 25 | K251978510(k) | LIAISON NES FLU A/B, RSV & COVID-19 | Diasorin Molecular, LLC | Microbiology | QOF |
| Dec 23, 25 | K251991510(k) | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | General Hospital | JOJ |
| Dec 23, 25 | K252145510(k) | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | Dental | DZE |
| Dec 23, 25 | K252146510(k) | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | Neurology | NFO |
| Dec 23, 25 | K252187510(k) | Aura Glide (FC40) | Aura Medical, LLC | Neurology | NFO |
| Dec 23, 25 | K252379510(k) | AIR Recon DL | Ge Medical Systems, LLC | Radiology | LNH |
| Dec 23, 25 | K252493510(k) | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) | Hycor Biomedical | Immunology | DHB |
| Dec 23, 25 | K252633510(k) | UNITY DX (UDX) | Cylite Pty. , Ltd. | Ophthalmic | OBO |
| Dec 23, 25 | K252835510(k) | Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. | Physical Medicine | INI |
| Dec 23, 25 | K253072510(k) | Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) | Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. | Obstetrics/Gynecology | HGX |
| Dec 23, 25 | K253091510(k) | ART-Plan+ (v3.1.0) | Therapanacea Sas | Radiology | MUJ |
| Dec 23, 25 | K253122510(k) | Sim&Size | Sim&Cure | Radiology | PZO |
| Dec 23, 25 | K253135510(k) | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) | Dongguan Yijiaming Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Dec 23, 25 | K253217510(k) | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | Orthopedic | HRX |
| Dec 23, 25 | K253239510(k) | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | Orthopedic | MBH |
| Dec 23, 25 | K253281510(k) | UpDoc | Updoc, Inc. | Anesthesiology | NDC |
| Dec 23, 25 | K253312510(k) | OrangeCAD Med Abutments | Orangecad Med GmbH | Dental | NHA |
| Dec 23, 25 | K253341510(k) | Custom Abutments AS | Medentika GmbH | Dental | NHA |
| Dec 23, 25 | K253567510(k) | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC | Clinical Toxicology | NGL |
| Dec 23, 25 | K253675510(k) | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | Orthopedic | KWL |
| Dec 23, 25 | K253740510(k) | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited | Neurology | NUH |
| Dec 23, 25 | K253754510(k) | Philips Lumea IPL | Philips Consumer Lifestyle B.V. | General, Plastic Surgery | OHT |
| Dec 23, 25 | K254163510(k) | VarioSurg 4 | Nakanishi, Inc. | Dental | DZI |
| Dec 22, 25 | K243342510(k) | KP Protective Face Mask | Kp Trading Co., Ltd. | General, Plastic Surgery | FXX |
| Dec 22, 25 | K250756510(k) | Pression Wave PRO External Counter-Pulsation System | Pression, Inc. | Cardiovascular | DRN |
| Dec 22, 25 | K250959510(k) | BioticsAI | Bioticsai, Inc. | Radiology | IYN |
| Dec 22, 25 | K251019510(k) | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | Bioteque Corporation | Gastroenterology, Urology | FGE |
| Dec 22, 25 | K251105510(k) | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | General Hospital | PKP |
| Dec 22, 25 | K251159510(k) | Power wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. | Physical Medicine | ITI |
| Dec 22, 25 | K251605510(k) | DIMPLO Implant System | DIMPLO, Ltd. | Dental | DZE |
| Dec 22, 25 | K251764510(k) | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. | Anesthesiology | CAW |
| Dec 22, 25 | K251783510(k) | Inspire HCR and HCR DUAL cardiotomy reservoirs | Sorin Group Italia S.R.L. | Cardiovascular | DTN |
| Dec 22, 25 | K252068510(k) | MC2 Portable X-ray System | Oxos Medical | Radiology | OWB |
| Dec 22, 25 | K252109510(k) | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | Radiology | MUJ |
| Dec 22, 25 | K252361510(k) | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | Cardiovascular | DPS |
| Dec 22, 25 | K252557510(k) | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | IYN |
| Dec 22, 25 | K252611510(k) | aprevo® cervical plating system | Carlsmed, Inc. | Orthopedic | KWQ |
| Dec 22, 25 | K252616510(k) | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | Anesthesiology | CAW |
| Dec 22, 25 | K252673510(k) | LacertaMatrix | Lacerta Life Science | Unknown | KGN |
| Dec 22, 25 | K252743510(k) | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | ETHICON, Inc. | General, Plastic Surgery | GAM |
| Dec 22, 25 | K252856510(k) | PeekMed web | Peek Health, S.A. | Radiology | QIH |
| Dec 22, 25 | K252981510(k) | EmbraceMini | Empatica S.r.l. | Neurology | LEL |
| Dec 22, 25 | K253222510(k) | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. | General Hospital | MMK |
| Dec 22, 25 | K253339510(k) | Theracor | Stimlabs, LLC | Unknown | KGN |
| Dec 22, 25 | K253661510(k) | TMINI Miniature Robotic System | THINK Surgical, Inc. | Neurology | OLO |
| Dec 22, 25 | K253664510(k) | SKOUT system | Iterative Health | Gastroenterology, Urology | QNP |
| Dec 22, 25 | K253727510(k) | Syndesmosis TightRope PRO | Arthrex, Inc. | Orthopedic | HTN |
| Dec 22, 25 | K253769510(k) | Instylla Delivery Kit | Instylla, Inc. | General Hospital | FMF |
| Dec 22, 25 | K253781510(k) | InnoClip Clip Applier | Taiwan Surgical Corporation | General, Plastic Surgery | FZP |
| Dec 22, 25 | K253876510(k) | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | Globus Medical, Inc. | Orthopedic | OVE |
| Dec 22, 25 | K253903510(k) | InnoClip Disposable Clip Applier | Taiwan Surgical Corporation | General, Plastic Surgery | FZP |
| Dec 22, 25 | P250019PMA | SAPIEN M3 Transcatheter Mitral Valve Replacement System | Edwards Lifesciences, LLC | Cardiovascular | NPU |
| Dec 19, 25 | K232365510(k) | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | Anesthesiology | CBK |
| Dec 19, 25 | K250314510(k) | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | Cardiovascular | PNE |
| Dec 19, 25 | K250864510(k) | MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG | Unknown | KGN |
| Dec 19, 25 | K250976510(k) | Airbile-100 | Poskom Co., Ltd. | Radiology | IZL |
| Dec 19, 25 | K250998510(k) | CO2 Laser Therapy System (Model: LFS-D9U) | Sanhe Lefis Electronics Co., Ltd. | General, Plastic Surgery | GEX |
| Dec 19, 25 | K251011510(k) | Chiavaye Personal Moisturizer | Unipack, LLC | Obstetrics/Gynecology | NUC |
| Dec 19, 25 | K251037510(k) | Rectal Applicator | Nucletron B.V. | Radiology | JAQ |
| Dec 19, 25 | K251050510(k) | Pectus Versa System | Gm Dos Reis Industria E Comercio | Orthopedic | HRS |
| Dec 19, 25 | K251074510(k) | Tru Liver Health Test Panel | Truvian Health | Clinical Chemistry | CJE |
| Dec 19, 25 | K251077510(k) | JOULE 1064nm System and Accessories | Sciton, Inc | General, Plastic Surgery | GEX |
| Dec 19, 25 | K251143510(k) | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. | Cardiovascular | DXN |
| Dec 19, 25 | K251152510(k) | DBLG2 | Diabeloop | Clinical Chemistry | QJI |
| Dec 19, 25 | K251402510(k) | LIA-1 Catheter (542-1) | Leadoptik, Inc. | Ear, Nose, Throat | KTI |
| Dec 19, 25 | K251469510(k) | Endura Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. | Gastroenterology, Urology | FAD |
| Dec 19, 25 | K251572510(k) | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | Anesthesiology | CAF |
| Dec 19, 25 | K251730510(k) | LIA Console (542-7) | Leadoptik, Inc. | Radiology | NQQ |
| Dec 19, 25 | K251751510(k) | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. | Cardiovascular | DQA |
| Dec 19, 25 | K252029510(k) | AI-CVD | HeartLung Corporation | Radiology | QIH |
| Dec 19, 25 | K252167510(k) | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | Unknown | FRO |
| Dec 19, 25 | K252284510(k) | eMurmur Heart AI | Csd Labs | Cardiovascular | DQD |
| Dec 19, 25 | K252342510(k) | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) | Guangdong Youmeng Electrical Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Dec 19, 25 | K252480510(k) | CE Deliver (DLV) | CapsoVision, Inc. | Gastroenterology, Urology | NEZ |
| Dec 19, 25 | K252670510(k) | Alzevita | TOPIA MEDTECH LIMITED | Radiology | QIH |
| Dec 19, 25 | K252754510(k) | Wearable Electric Breast Pump (YM-8803) | Guangdong Youmeng Electrical Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Dec 19, 25 | K252780510(k) | LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. | Radiology | PGY |
| Dec 19, 25 | K252781510(k) | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. | Orthopedic | ODP |
| Dec 19, 25 | K252838510(k) | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | Siemens Healthcare GmbH | Radiology | LNH |
| Dec 19, 25 | K252863510(k) | ClearCalc Model RADCA V2.6 | Radformation, Inc. | Radiology | MUJ |
| Dec 19, 25 | K252877510(k) | SANDRO Dual | Wontech Co., Ltd. | General, Plastic Surgery | GEX |
| Dec 19, 25 | K252892510(k) | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | General, Plastic Surgery | NEU |
| Dec 19, 25 | K252974510(k) | EMPOWR Knee | Encore Medical L.P. | Orthopedic | JWH |
| Dec 19, 25 | K253054510(k) | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | General, Plastic Surgery | OHS |
| Dec 19, 25 | K253086510(k) | LED Light Therapy Device (Models: SG-FM, SG-FE) | Sunglor Technology Co., Ltd. | General, Plastic Surgery | OHS |
| Dec 19, 25 | K253161510(k) | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | Orthopedic | MBH |
| Dec 19, 25 | K253202510(k) | Hoffmann LRF System | Stryker GmbH | Orthopedic | KTT |
| Dec 19, 25 | K253358510(k) | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Diazyme Laboratories, Inc. | Immunology | DFH |
| Dec 19, 25 | K253373510(k) | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | Dental | JEY |
| Dec 19, 25 | K253409510(k) | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | Cardiovascular | DQY |
| Dec 19, 25 | K253479510(k) | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. | Anesthesiology | BTT |
| Dec 19, 25 | K253577510(k) | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | Orthopedic | MAX |
| Dec 19, 25 | K253613510(k) | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | Orthopedic | KTT |
| Dec 19, 25 | K253616510(k) | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | Cardiovascular | DRE |
| Dec 19, 25 | K253733510(k) | STAR Apollo Mapping System | Rhythm AI, Ltd. | Cardiovascular | DQK |
| Dec 19, 25 | K254063510(k) | iCEM Universal Plus | Kulzer, LLC | Dental | EMA |
| Dec 19, 25 | P250017PMA | GORE® VIABAHN® FORTEGRA Venous Stent | W. L. Gore & Associates, Inc. | Cardiovascular | QTL |
| Dec 19, 25 | P250022PMA | Volt PFA System | ABBOTT MEDICAL | Cardiovascular | QZI |
| Dec 18, 25 | K250914510(k) | MediAI-BA | Crescom Co., Ltd. | Radiology | QIH |
| Dec 18, 25 | K250993510(k) | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation | Gastroenterology, Urology | FDX |
| Dec 18, 25 | K251562510(k) | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | Gastroenterology, Urology | PKL |
| Dec 18, 25 | K251915510(k) | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | Cardiovascular | LIT |
| Dec 18, 25 | K252071510(k) | RefleXion Medical Radiotherapy System, Reflexion X2 | Reflexion Medical, Inc. | Radiology | QVA |
| Dec 18, 25 | K252235510(k) | PVAD IQ Software | Ultrasight , Ltd. | Radiology | QIH |
| Dec 18, 25 | K252320510(k) | SIMDA Abutments | Simda Co., Ltd. | Dental | NHA |
| Dec 18, 25 | K252348510(k) | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | Ophthalmic | MXK |
| Dec 18, 25 | K252402510(k) | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | General Hospital | PND |
| Dec 18, 25 | K252533510(k) | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | Cardiovascular | DQK |
| Dec 18, 25 | K252793510(k) | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) | Jiangsu Jiyuan Medical Technology Co., Ltd. | Obstetrics/Gynecology | HIH |
| Dec 18, 25 | K252956510(k) | Helo Thrombectomy System | Endovascular Engineering, Inc. | Cardiovascular | QEW |
| Dec 18, 25 | K252976510(k) | Park Dental Nylon MAD | Park Dental Research Corp. | Dental | LRK |
| Dec 18, 25 | K253516510(k) | Assert-IQ (DM5100) | ABBOTT MEDICAL | Cardiovascular | MXD |
| Dec 18, 25 | K253518510(k) | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC | Gastroenterology, Urology | KDI |
| Dec 18, 25 | K253758510(k) | Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) | Unknown | OLR |
| Dec 18, 25 | K253915510(k) | MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH | General, Plastic Surgery | GEI |
| Dec 17, 25 | K250854510(k) | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) | Shenzhen Comen Medical Instruments Co.,Ltd | Cardiovascular | MHX |
| Dec 17, 25 | K251416510(k) | UltraSight Guidance | Ultrasight , Ltd. | Radiology | QJU |
| Dec 17, 25 | K252191510(k) | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG | Orthopedic | HRS |
| Dec 17, 25 | K252398510(k) | SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | General Hospital | FOZ |
| Dec 17, 25 | K252417510(k) | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | Cardiovascular | DQY |
| Dec 17, 25 | K252508510(k) | Intri26 Introducer Sheath | Inari Medical, Inc. | Cardiovascular | DYB |
| Dec 17, 25 | K252518510(k) | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | General Hospital | FMF |
| Dec 17, 25 | K252739510(k) | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) | Ethicon Endo-Surgery, LLC | General, Plastic Surgery | GDW |
| Dec 17, 25 | K252922510(k) | Neosoma Brain Mets | Neosoma, Inc. | Radiology | QIH |
| Dec 17, 25 | K252983510(k) | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | Shenzhen Goodwind Technology Development Co., Ltd. | General, Plastic Surgery | OHS |
| Dec 17, 25 | K253093510(k) | Vital Spinal Fixation System | Highridge Medical, LLC | Orthopedic | NKB |
| Dec 17, 25 | K253710510(k) | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | Clinical Chemistry | QBJ |
| Dec 17, 25 | K253719510(k) | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | Obstetrics/Gynecology | HEB |
| Dec 17, 25 | K253721510(k) | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | Orthopedic | NKB |
| Dec 17, 25 | K253839510(k) | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | Microbiology | QVP |
| Dec 16, 25 | K250925510(k) | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | Immunology | OVK |
| Dec 16, 25 | K251256510(k) | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | Pentax of America, Inc. | Gastroenterology, Urology | FDS |
| Dec 16, 25 | K251745510(k) | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation | Cardiovascular | DXQ |
| Dec 16, 25 | K251763510(k) | IRISeg | Intuitive Surgical, Inc. | Radiology | QIH |
| Dec 16, 25 | K251771510(k) | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | Orthopedic | HSX |
| Dec 16, 25 | K251893510(k) | SKAN C PULSAR | Skanray Technologies Limited | Radiology | OWB |
| Dec 16, 25 | K251951510(k) | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | Gastroenterology, Urology | FGB |
| Dec 16, 25 | K252111510(k) | Versius Surgical System (Versius Plus) | Cmr Surgical Limited | General, Plastic Surgery | SCV |
| Dec 16, 25 | K252204510(k) | prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. | Cardiovascular | PPW |
| Dec 16, 25 | K252268510(k) | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | Anesthesiology | CAW |
| Dec 16, 25 | K252373510(k) | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology | Spectrum Vascular | General Hospital | LJS |
| Dec 16, 25 | K252468510(k) | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) | Zhejiang Geyi Medical Instrument Co., Ltd. | Gastroenterology, Urology | FGB |
| Dec 16, 25 | K252919510(k) | IDENTIFY (5.0) | Varian Medical Systems, Inc. | Radiology | IYE |
| Dec 16, 25 | K252940510(k) | VR® Personal Protective Level 3 Gown (VR Gowns) | PolyConversions, Inc. | General, Plastic Surgery | QPC |
| Dec 16, 25 | K253118510(k) | Companion Spine DIAM Instrumentation | Companion Spine France | Orthopedic | QLR |
| Dec 16, 25 | K253620510(k) | TroClose 1200 | Gordian Surgical, Ltd. | General, Plastic Surgery | GAM |
| Dec 15, 25 | K250319510(k) | MFUSE (MS001) | Machina Medical, Inc. | Unknown | QSY |
| Dec 15, 25 | K251302510(k) | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | Orthopedic | OQB |
| Dec 15, 25 | K251770510(k) | SleepRes PAP System | Sleepres, Inc. | Anesthesiology | BZD |
| Dec 15, 25 | K252574510(k) | Erchonia CLX (Model # CFL) | Erchonia Corporation | General, Plastic Surgery | OLI |
| Dec 15, 25 | K252675510(k) | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | Gastroenterology, Urology | NAY |
| Dec 15, 25 | K252898510(k) | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Orthopedic | KRO |
| Dec 15, 25 | K252935510(k) | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) | Foshan Pingchuang Medical Technology Co., Ltd. | Obstetrics/Gynecology | NUC |
| Dec 15, 25 | K252950510(k) | Paradigm System | Proprio, Inc. | Neurology | OLO |
| Dec 15, 25 | K253101510(k) | HyperVue Imaging System - Integrated | Spectrawave, Inc. | Radiology | NQQ |
| Dec 15, 25 | K253403510(k) | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. | Obstetrics/Gynecology | LKF |
| Dec 15, 25 | K253677510(k) | Tembo Embolic System | Instylla, Inc. | Cardiovascular | KRD |
| Dec 15, 25 | K253741510(k) | VStick Vascular Access Set | Argon Medical Devices, Inc. | Cardiovascular | DYB |
| Dec 15, 25 | P240035PMA | ETHIZIA | ETHICON, Inc. | General, Plastic Surgery | SGV |
| Dec 14, 25 | K250851510(k) | Hypnos (369054-200) | Cadwell Industries, Inc. | Neurology | OLZ |
| Dec 12, 25 | K242817510(k) | Jason membrane | Botiss Biomaterials GmbH | Dental | NPL |
| Dec 12, 25 | K250488510(k) | Cerynë Intimate Care | Ansella Therapeutics | Obstetrics/Gynecology | NUC |
| Dec 12, 25 | K250821510(k) | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | Eurosets S.R.L | Cardiovascular | DTZ |
| Dec 12, 25 | K250847510(k) | VaporShield | Vault Paragon Group, Inc. | General Hospital | MEG |
| Dec 12, 25 | K250863510(k) | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | Ear, Nose, Throat | EOQ |
| Dec 12, 25 | K250974510(k) | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | Cardiovascular | JOW |
| Dec 12, 25 | K251085510(k) | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro | Ihealth Labs, Inc. | Microbiology | SCA |
| Dec 12, 25 | K251089510(k) | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | General Hospital | FMF |
| Dec 12, 25 | K251092510(k) | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | Ihealth Labs, Inc. | Microbiology | SCA |
| Dec 12, 25 | K251177510(k) | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | General Hospital | FRG |
| Dec 12, 25 | K251989510(k) | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. | General, Plastic Surgery | NEU |
| Dec 12, 25 | K252090510(k) | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | Dental | DZE |
| Dec 12, 25 | K252120510(k) | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | Ophthalmic | HKI |
| Dec 12, 25 | K252273510(k) | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | Physical Medicine | NHN |
| Dec 12, 25 | K252391510(k) | Revi System | Bluewind Medical , Ltd. | Gastroenterology, Urology | QXM |
| Dec 12, 25 | K252681510(k) | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | Gastroenterology, Urology | KNW |
| Dec 12, 25 | K252745510(k) | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) | Micro-Energy Medical Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Dec 12, 25 | K252785510(k) | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | Dental | EMA |
| Dec 12, 25 | K253489510(k) | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | Radiology | LNH |
| Dec 12, 25 | K253609510(k) | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | Unknown | QSY |
| Dec 12, 25 | K253749510(k) | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | Orthopedic | HSB |
| Dec 11, 25 | K250988510(k) | KLS Martin Pure Pectus System | KLS-Martin L.P. | Orthopedic | HRS |
| Dec 11, 25 | K251883510(k) | MIM LesionID Pro | Mim Software, Inc. | Radiology | LLZ |
| Dec 11, 25 | K252482510(k) | CogNet AI-MT+ | Medcognetics, Inc. | Radiology | QFM |
| Dec 11, 25 | K252694510(k) | Target Detachable Coil | Stryker Neurovascular | Neurology | HCG |
| Dec 11, 25 | K252897510(k) | APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista | A Plus Biotechnology Co., Ltd. | Orthopedic | HRS |
| Dec 11, 25 | K252941510(k) | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. | General, Plastic Surgery | FXX |
| Dec 11, 25 | K252997510(k) | HyperFlex® Bunion Correction System | Hyperflex Medical | Orthopedic | HRS |
| Dec 11, 25 | K253141510(k) | DeepRhythmAI | Medicalgorithmics S.A. | Cardiovascular | DQK |
| Dec 11, 25 | K253200510(k) | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | Orthopedic | OVE |
| Dec 11, 25 | P250007PMA | Zenflow Spring® Implant and Delivery System | Zenflow, Inc. | Gastroenterology, Urology | MER |
| Dec 10, 25 | K250192510(k) | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | General Hospital | FMF |
| Dec 10, 25 | K251598510(k) | Intellidrop | Brainspace, Inc. | Neurology | JXG |
| Dec 10, 25 | K252497510(k) | SANSA HSAT | Huxley Medical | Anesthesiology | MNR |
| Dec 10, 25 | K252826510(k) | ARIX Femur Nail System | Jeil Medical Corporation | Orthopedic | HSB |
| Dec 10, 25 | P240043PMA | DIAM Spinal Stabilization System | Companion Spine France Sas | Orthopedic | NQO |
| Dec 9, 25 | K243449510(k) | INFINITT DPS | Infinitt Healthcare Co., Ltd. | Pathology | QKQ |
| Dec 9, 25 | K250742510(k) | Focused Cryotherapy System | Focused Cryo, Inc. | General, Plastic Surgery | GEH |
| Dec 9, 25 | K250805510(k) | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | Anesthesiology | CAW |
| Dec 9, 25 | K251199510(k) | Allia Moveo | GE Medical Systems SCS | Radiology | OWB |
| Dec 9, 25 | K252154510(k) | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. | Physical Medicine | NGX |
| Dec 9, 25 | K252343510(k) | Atlantis® Abutments in Titanium | Dentsply Sirona | Dental | NHA |
| Dec 9, 25 | K252808510(k) | GlasIonomer FX-LC | Shofu Dental Corporation | Dental | EMA |
| Dec 9, 25 | K253706510(k) | Lancing device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. | General, Plastic Surgery | QRL |
| Dec 9, 25 | P250011PMA | ProVee System for BPH | Proverum, Ltd. | Gastroenterology, Urology | MER |
| Dec 8, 25 | K250190510(k) | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | Cardiovascular | JOW |
| Dec 8, 25 | K250258510(k) | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | Cardiovascular | DXH |
| Dec 8, 25 | K251829510(k) | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | Orthopedic | OVD |
| Dec 8, 25 | K251936510(k) | Ceribell Delirium Monitor System | Ceribell, Inc. | Neurology | NCG |
| Dec 8, 25 | K252294510(k) | Fetal EchoScan (v1.2) | Brightheart | Radiology | POK |
| Dec 8, 25 | K252789510(k) | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | Dental | EIH |
| Dec 8, 25 | K252862510(k) | Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co., Ltd. | Physical Medicine | ITI |
| Dec 8, 25 | K252994510(k) | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) | Guangdong Ace-Tec Co., Ltd. | General, Plastic Surgery | OHS |
| Dec 8, 25 | P230024PMA | Flow FL-100 | Flow Neuroscience AB | Neurology | JXK |
| Dec 5, 25 | K243438510(k) | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | Cardiovascular | DXH |
| Dec 5, 25 | K250512510(k) | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | Dental | NPL |
| Dec 5, 25 | K250711510(k) | VSP Orthopedics System | 3D Systems, Inc. | Orthopedic | PBF |
| Dec 5, 25 | K250743510(k) | Remvia NightGuard | Remvia | Unknown | MQC |
| Dec 5, 25 | K250764510(k) | SpineLinc Anterior Cervical Implant System | Lincotek Medical | Orthopedic | ODP |
| Dec 5, 25 | K250780510(k) | ARTAssistant | Manteia Technologies Co., Ltd. | Radiology | QKB |
| Dec 5, 25 | K250795510(k) | PUREVUE FMS | W.O.M. World of Medicine GmbH | Orthopedic | HRX |
| Dec 5, 25 | K251337510(k) | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | Microbiology | JTN |
| Dec 5, 25 | K251403510(k) | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) | Dornier Medtech America Inc (Dmta) | Gastroenterology, Urology | FAS |
| Dec 5, 25 | K251514510(k) | Overjet CBCT Assist | Overjet, Inc. | Radiology | QIH |
| Dec 5, 25 | K251657510(k) | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | Anesthesiology | BZD |
| Dec 5, 25 | K251722510(k) | ProSeal Transfer Injector (421120, 421130, 421140) | Epic Medical Pte. , Ltd. | General Hospital | ONB |
| Dec 5, 25 | K251731510(k) | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG | Ear, Nose, Throat | EOQ |
| Dec 5, 25 | K252067510(k) | Velora Acetabular System | Restor3D, Inc. | Orthopedic | LPH |
| Dec 5, 25 | K252142510(k) | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | General, Plastic Surgery | OHS |
| Dec 5, 25 | K252151510(k) | els unibond | Saremco Dental AG | Dental | KLE |
| Dec 5, 25 | K252296510(k) | OncoPatch | Oncopatch, Inc. | Radiology | KXK |
| Dec 5, 25 | K252465510(k) | Any-Core | Mediclus Co., Ltd. | Dental | EBF |
| Dec 5, 25 | K252494510(k) | Electrically powered wheelchair (KZ301B) | Nanjing Kangni Smart Technology Co., Ltd. | Physical Medicine | ITI |
| Dec 5, 25 | K252498510(k) | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) | Sonoscape Medical Corp. | Radiology | IYN |
| Dec 5, 25 | K252504510(k) | Gastric Alimetry | Alimetry , Ltd. | Gastroenterology, Urology | MYE |
| Dec 5, 25 | K252605510(k) | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC | Gastroenterology, Urology | FFX |
| Dec 5, 25 | K252825510(k) | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Physical Medicine | IOR |
| Dec 5, 25 | K252828510(k) | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Physical Medicine | IOR |
| Dec 5, 25 | K252841510(k) | REAL INTELLIGENCE CORI XT (CORI XT) | Blue Belt Technologies, Inc. | Neurology | OLO |
| Dec 5, 25 | K253868510(k) | QuietLab Pro | QuietLab, LLC | Dental | LRK |
| Dec 4, 25 | K250679510(k) | FFX Facet Fixation System | Sc Medica | Unknown | MRW |
| Dec 4, 25 | K250791510(k) | ASUS Ultrasound Imaging System (LU800 series) | Asustek Computer, Inc. | Radiology | IYN |
| Dec 4, 25 | K250816510(k) | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | Immunology | JNL |
| Dec 4, 25 | K251257510(k) | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | General Hospital | FPA |
| Dec 4, 25 | K251943510(k) | Spineology Navigation Instruments | Spineology, Inc. | Neurology | OLO |
| Dec 4, 25 | K252126510(k) | MitraPatch Mitral Valve Repair System | Chawla Heart Technologies, LLC | Cardiovascular | PAW |
| Dec 4, 25 | K252429510(k) | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | Cardiovascular | DQK |
| Dec 4, 25 | K252588510(k) | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. | Physical Medicine | INI |
| Dec 4, 25 | K252596510(k) | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | Orthopedic | MBI |
| Dec 3, 25 | K250564510(k) | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | General, Plastic Surgery | FYA |
| Dec 3, 25 | K250692510(k) | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | Radiology | JAD |
| Dec 3, 25 | K250725510(k) | Hugo RAS System | Covidien, LLC | General, Plastic Surgery | SCV |
| Dec 3, 25 | K251203510(k) | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | Radiology | OEB |
| Dec 3, 25 | K251601510(k) | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Radiology | IYN |
| Dec 3, 25 | K251779510(k) | Omnipod 5 algorithm | Insulet Corporation | Clinical Chemistry | QJI |
| Dec 3, 25 | K251881510(k) | HippoMind (v1.0) | Hippoclinic | Neurology | OLT |
| Dec 3, 25 | K252213510(k) | Bendit17 Microcatheter | Bend IT Technologies, Ltd. | Cardiovascular | QJP |
| Dec 3, 25 | K253293510(k) | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | Cardiovascular | DSH |
| Dec 3, 25 | P240021PMA | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | Immunology | MTF |
| Dec 2, 25 | K250884510(k) | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | Becton, Dickinson and Company | General Hospital | NGT |
| Dec 2, 25 | K250896510(k) | Aura Wave | Aura Wellness, LLC | Physical Medicine | SGT |
| Dec 2, 25 | K252021510(k) | Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. | Gastroenterology, Urology | FBK |
| Dec 2, 25 | K252069510(k) | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | Gastroenterology, Urology | NAY |
| Dec 2, 25 | K252103510(k) | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | Radiology | QIH |
| Dec 1, 25 | K250713510(k) | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | Exactech, Inc. | Orthopedic | KWT |
| Dec 1, 25 | K251370510(k) | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | Radiology | KPS |
| Dec 1, 25 | K251691510(k) | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Unimed Medical Supplies, Inc. | Cardiovascular | DQA |
| Dec 1, 25 | K251696510(k) | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Unimed Medical Supplies, Inc. | Cardiovascular | DQA |
| Dec 1, 25 | K252786510(k) | Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited. | General, Plastic Surgery | OLI |
| Dec 1, 25 | K252827510(k) | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | Drägerwerk AG & Co. KGaA | Cardiovascular | DSA |
| Dec 1, 25 | K253250510(k) | Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC | Orthopedic | PEK |
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.