The Tracker // June 2026
June 2026: 331 FDA device decisions
325 510(k) clearances and 6 original PMA approvals with a decision date in June 2026. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Jun 30, 26 | K253767510(k) | UB ERP System | Universal Brain | Neurology | OLT |
| Jun 30, 26 | K260576510(k) | MeVis AVM Contour | MeVis Medical Solutions AG | Radiology | LLZ |
| Jun 30, 26 | K261068510(k) | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical | General, Plastic Surgery | GEH |
| Jun 30, 26 | K261101510(k) | Ceribell Monitor | Ceribell, Inc. | Neurology | OMC |
| Jun 30, 26 | K261119510(k) | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | Cardiovascular | DQK |
| Jun 30, 26 | K261808510(k) | ISAAC Neurovascular Navigation Catheter | Microvention Inc. d/b/a Terumo Neuro | Cardiovascular | QJP |
| Jun 30, 26 | K262195510(k) | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | Dental | EIH |
| Jun 29, 26 | K251492510(k) | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | General, Plastic Surgery | GEI |
| Jun 29, 26 | K253484510(k) | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | General, Plastic Surgery | GEI |
| Jun 29, 26 | K253628510(k) | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | Radiology | QIH |
| Jun 29, 26 | K253969510(k) | ADAS 3D | Adas3D Medical S.L. | Radiology | QIH |
| Jun 29, 26 | K254149510(k) | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | Sterilmed, Inc. | Cardiovascular | OWQ |
| Jun 29, 26 | K260667510(k) | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | IYN |
| Jun 29, 26 | K260918510(k) | Zolid Lunaris | Amann Girrbach AG | Dental | EIH |
| Jun 29, 26 | K261052510(k) | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. | General, Plastic Surgery | OHS |
| Jun 29, 26 | K261415510(k) | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. | Dental | KIF |
| Jun 29, 26 | K261461510(k) | Omnipod 6 algorithm | Insulet Corporation | Clinical Chemistry | QJI |
| Jun 29, 26 | K261481510(k) | Pangea Femur Reconstruction System | Stryker GmbH | Orthopedic | HSB |
| Jun 27, 26 | K253301510(k) | BraiN20® (BraiN20) | Time IS Brain, S.L. | Neurology | GWF |
| Jun 27, 26 | K253390510(k) | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | Neurology | OLZ |
| Jun 27, 26 | K261122510(k) | MIST IC | Imagine Milling Technologies, LLC | Dental | NHA |
| Jun 26, 26 | K250070510(k) | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Jun 26, 26 | K253306510(k) | BioTracker 2.0 | Biotracker, LLC | Unknown | |
| Jun 26, 26 | K253316510(k) | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | Microbiology | SAN |
| Jun 26, 26 | K253921510(k) | VERTICALE® Navigation Instruments | Silony Medical GmbH | Neurology | OLO |
| Jun 26, 26 | K254232510(k) | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | Edwards Lifesciences | General, Plastic Surgery | PZX |
| Jun 26, 26 | K260018510(k) | Arthrex FiberButton | Arthrex, Inc. | Orthopedic | MBI |
| Jun 26, 26 | K260061510(k) | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | Dental | NHA |
| Jun 26, 26 | K260412510(k) | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | Neurology | NUH |
| Jun 26, 26 | K260714510(k) | MammoScreen® (5) | Therapixel | Radiology | QDQ |
| Jun 26, 26 | K261039510(k) | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Clinical Chemistry | CGL |
| Jun 26, 26 | K261253510(k) | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5) | Ziree Co., Ltd. | Physical Medicine | OAP |
| Jun 26, 26 | K261351510(k) | SALGINA 2.5mm Distal Radius System | Bonebridge AG | Orthopedic | HRS |
| Jun 26, 26 | K261442510(k) | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | Neurology | GXY |
| Jun 26, 26 | K261455510(k) | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | Cardiovascular | DQO |
| Jun 26, 26 | K261745510(k) | LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical | Cardiovascular | DXF |
| Jun 26, 26 | P250055PMA | AMDS Hybrid Prosthesis | Artivion, Inc. | Cardiovascular | QSK |
| Jun 25, 26 | K251188510(k) | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | Dental | DZE |
| Jun 25, 26 | K252584510(k) | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | Weyo Surgical Technology , Ltd. | Obstetrics/Gynecology | HIF |
| Jun 25, 26 | K253216510(k) | IntraOp Alignment System; CONTOUR3D Bending System | Alphatec Spine, Inc. | Orthopedic | SIN |
| Jun 25, 26 | K253274510(k) | BedDot (G1) | Intelligent Dots, LLC | Anesthesiology | BZQ |
| Jun 25, 26 | K253330510(k) | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Anesthesiology | BSZ |
| Jun 25, 26 | K253367510(k) | EliA CTD 13 Screen | Phadia AB | Immunology | LLL |
| Jun 25, 26 | K253384510(k) | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | Seers Technology Co., Ltd. | Cardiovascular | MWJ |
| Jun 25, 26 | K253386510(k) | DVT Garment | Vistar Medical Supplies Co., Ltd. | Cardiovascular | JOW |
| Jun 25, 26 | K253394510(k) | Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | ETHICON, Inc. | General, Plastic Surgery | GAM |
| Jun 25, 26 | K253786510(k) | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | Radiology | QIH |
| Jun 25, 26 | K254108510(k) | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | Ear, Nose, Throat | QUH |
| Jun 25, 26 | K260231510(k) | MiPACS V5 (1.0.0) | Apryse Software Corp | Radiology | LLZ |
| Jun 25, 26 | K260480510(k) | VELYS Robotic-Assisted Solution | Depuy Ireland UC | Neurology | OLO |
| Jun 25, 26 | K260709510(k) | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) | Longeviti Neuro Solutions | Neurology | GXN |
| Jun 25, 26 | K260790510(k) | G-Series Grind Guard | ASESSO HEALTH, Inc. | Unknown | OBR |
| Jun 25, 26 | K260809510(k) | Arthrex Sterile VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | Orthopedic | HWC |
| Jun 25, 26 | K260992510(k) | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | Neuralytix | Ear, Nose, Throat | PDQ |
| Jun 25, 26 | K261025510(k) | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Jun 25, 26 | K261242510(k) | SimplGuide | Pendracare | Cardiovascular | DYB |
| Jun 25, 26 | K261458510(k) | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | Orthopedic | JWH |
| Jun 24, 26 | K251929510(k) | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | Unknown | FRO |
| Jun 24, 26 | K252117510(k) | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | General Hospital | LZA |
| Jun 24, 26 | K253263510(k) | ConvaVAC Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | General, Plastic Surgery | OMP |
| Jun 24, 26 | K253393510(k) | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 | Hangzhou AGS MedTech Co., Ltd. | Gastroenterology, Urology | FGE |
| Jun 24, 26 | K253404510(k) | CLEAR Aspiration System | Insera Therapeutics, Inc. | Unknown | |
| Jun 24, 26 | K253560510(k) | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | Radiology | JAK |
| Jun 24, 26 | K260394510(k) | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | Hangzhou Jimushi Meditech Co., Ltd. | Gastroenterology, Urology | EZD |
| Jun 24, 26 | K260669510(k) | Endoform Dermal Template | Aroa Biosurgery , Ltd. | Unknown | KGN |
| Jun 24, 26 | K260937510(k) | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd | Physical Medicine | ITI |
| Jun 24, 26 | K260998510(k) | Ceribell Neurology Review Software | Ceribell, Inc. | Neurology | OMB |
| Jun 24, 26 | K261023510(k) | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | Unknown | FRO |
| Jun 24, 26 | K261055510(k) | AMSCO 700 Steam Sterilizer | STERIS Corporation | General Hospital | FLE |
| Jun 24, 26 | K261260510(k) | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | Gastroenterology, Urology | FET |
| Jun 24, 26 | K261772510(k) | Target Xtra Detachable Coil | Stryker Neurovscular | Neurology | HCG |
| Jun 24, 26 | K261866510(k) | Concerto Versa Detachable Coil | Medtronic, Inc. | Cardiovascular | KRD |
| Jun 23, 26 | K253180510(k) | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | Anesthesiology | BZH |
| Jun 23, 26 | K253199510(k) | CURASYS 2 (EMDN0003) | CG Bio Co., Ltd. | General, Plastic Surgery | OMP |
| Jun 23, 26 | K253211510(k) | AQUABEAM Robotic System | Procept Biorobotics | General, Plastic Surgery | PZP |
| Jun 23, 26 | K261004510(k) | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | Integra Lifesciences Production Corporation | Neurology | JXG |
| Jun 22, 26 | K253148510(k) | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | Anesthesiology | MNR |
| Jun 22, 26 | K253176510(k) | TearView | Beyond 700 Pty, Ltd. | Ophthalmic | HKI |
| Jun 22, 26 | K253421510(k) | Perfusion Measurement Platform v1 | Quantified Imaging Limited | Radiology | LLZ |
| Jun 22, 26 | K254011510(k) | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | Obstetrics/Gynecology | NUC |
| Jun 22, 26 | K254287510(k) | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | Cardiovascular | DXQ |
| Jun 22, 26 | K260316510(k) | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | Radiology | QIH |
| Jun 22, 26 | K261075510(k) | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | Physical Medicine | IOR |
| Jun 22, 26 | K261076510(k) | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | Physical Medicine | IOR |
| Jun 22, 26 | K261279510(k) | DeltaNEC Interbody System | Nexus Spine | Orthopedic | OVE |
| Jun 22, 26 | K261342510(k) | Urocross Expander System (UES-2018-C1) | Prodeon Medical, Inc. | Gastroenterology, Urology | QKA |
| Jun 22, 26 | K261950510(k) | Health Line Tearaway Introducer | Health Line International Corporation | Cardiovascular | DYB |
| Jun 22, 26 | P240033PMA | LungFX device | Lung Bioengineering, Inc. | Gastroenterology, Urology | PHO |
| Jun 20, 26 | K260369510(k) | Dynamis Robotic Surgical System | LEM Surgical AG | Neurology | OLO |
| Jun 18, 26 | DEN250025510(k) | Syncron-E | Autonomous Healthcare, Inc. | Anesthesiology | QVC |
| Jun 18, 26 | K250806510(k) | Dental Implant System | A.B. Dental Devices , Ltd. | Dental | DZE |
| Jun 18, 26 | K251232510(k) | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | Dental | DZE |
| Jun 18, 26 | K251559510(k) | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | General Hospital | QVB |
| Jun 18, 26 | K252066510(k) | inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20) | Vincent Healthcare Products Limited | Anesthesiology | BZE |
| Jun 18, 26 | K252839510(k) | ZywieZ3 Sensor & Adhesive | Zywie, Inc. | Cardiovascular | MWJ |
| Jun 18, 26 | K252982510(k) | CONDUIT ZERO-P VA Secured Spacer System | Avalign Technologies, Inc. | Orthopedic | OVE |
| Jun 18, 26 | K253050510(k) | RadOncAI | Informai | Radiology | MUJ |
| Jun 18, 26 | K253058510(k) | Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. | Radiology | IZL |
| Jun 18, 26 | K253080510(k) | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | Orthopedic | HSB |
| Jun 18, 26 | K253110510(k) | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | General Hospital | FMF |
| Jun 18, 26 | K253116510(k) | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | Neurology | GXN |
| Jun 18, 26 | K253126510(k) | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | Cardiovascular | DXN |
| Jun 18, 26 | K253131510(k) | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | Dental | EBZ |
| Jun 18, 26 | K253187510(k) | SteriBest® Sterilization Tray System | Mastel Surgical | General Hospital | KCT |
| Jun 18, 26 | K253521510(k) | ECMT-100 WMD | Ecm Therapeutics, Inc. | Unknown | KGN |
| Jun 18, 26 | K253678510(k) | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | Radiology | MUE |
| Jun 18, 26 | K253776510(k) | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | Dental | DZI |
| Jun 18, 26 | K253812510(k) | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Physical Medicine | ITI |
| Jun 18, 26 | K253824510(k) | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | General Hospital | LZA |
| Jun 18, 26 | K254169510(k) | SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | Cardiovascular | QME |
| Jun 18, 26 | K254254510(k) | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Jun 18, 26 | K260178510(k) | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | Gastroenterology, Urology | KPI |
| Jun 18, 26 | K260190510(k) | ARTHUR | ROPCA ApS | Radiology | IYO |
| Jun 18, 26 | K260280510(k) | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | Hycor Biomedical | Immunology | DHB |
| Jun 18, 26 | K260636510(k) | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | General, Plastic Surgery | GEI |
| Jun 18, 26 | K260729510(k) | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | Radiology | QAS |
| Jun 18, 26 | K260820510(k) | VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | Radiology | MQB |
| Jun 18, 26 | K260946510(k) | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Guangdong Newdermo Biotech Co., Ltd. | General, Plastic Surgery | OHS |
| Jun 18, 26 | K261099510(k) | Blood Volume Analyzer (200) | Daxor Corporation | Hematology | JWO |
| Jun 18, 26 | K261246510(k) | SRGC-06 | GC America, Inc. | Dental | EBF |
| Jun 18, 26 | K261651510(k) | Precice Max System and Precice Ankle Salvage System | NuVasive Specialized Orthopedics | Orthopedic | HSB |
| Jun 18, 26 | K261665510(k) | CORUS Navigation System-GN | Providence Medical Technology, Inc. | Neurology | OLO |
| Jun 18, 26 | K261701510(k) | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Jun 18, 26 | K261707510(k) | MEMO 4D Curve Semirigid mitral annuloplasty ring | Corcym S.r.l. | Cardiovascular | KRH |
| Jun 18, 26 | K261713510(k) | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | Radiology | QIH |
| Jun 18, 26 | P220016PMA | HepQuant SHUNT® Liver Diagnostic Test | Hepquant, LLC | Clinical Chemistry | SIO |
| Jun 17, 26 | K252399510(k) | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | Anesthesiology | CAW |
| Jun 17, 26 | K253045510(k) | Socko Vimax Spinal Fixation System | Socko Medical Co., Ltd. | Orthopedic | NKB |
| Jun 17, 26 | K253055510(k) | Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) | Nordic Kinetics AB | Neurology | GYD |
| Jun 17, 26 | K253155510(k) | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | Orthopedic | HSB |
| Jun 17, 26 | K253255510(k) | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Foshan Pingchuang Medical Technology Co., Ltd. | Radiology | MUI |
| Jun 17, 26 | K253333510(k) | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | Obstetrics/Gynecology | MRX |
| Jun 17, 26 | K253634510(k) | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | General, Plastic Surgery | GEI |
| Jun 17, 26 | K260006510(k) | INOSS System | Inosys, Inc. | Dental | DZE |
| Jun 17, 26 | K260428510(k) | RIVOS EUS Access Device (M00553900) | Boston Scientific Corporation | Gastroenterology, Urology | ODG |
| Jun 17, 26 | K260538510(k) | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Jun 17, 26 | K260867510(k) | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. | General Hospital | LZA |
| Jun 17, 26 | K260916510(k) | FLEXI-PORT Power Injectable Implantable Port | Portal Access, Inc. | General Hospital | LJT |
| Jun 17, 26 | K261544510(k) | Hydro Irrigation System | Stryker Instruments | Ear, Nose, Throat | EOB |
| Jun 17, 26 | K261570510(k) | PICOSURE WORKSTATION | Cynosure, LLC | General, Plastic Surgery | GEX |
| Jun 17, 26 | K261631510(k) | Amplatzer TorqVue Exchange System | Abbott Medical | Cardiovascular | DQY |
| Jun 17, 26 | K261638510(k) | Bonvadis® | Oneness Biotech Co., Ltd. | Unknown | FRO |
| Jun 17, 26 | K261672510(k) | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | Clinical Chemistry | QFG |
| Jun 16, 26 | K253001510(k) | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Hunan Ruijiong Biotech Co., Ltd. | Anesthesiology | NHJ |
| Jun 16, 26 | K253046510(k) | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | Orthopedic | HSB |
| Jun 16, 26 | K253069510(k) | Lipoprotein (a) Molarity Assay | Diazyme Laboratories, Inc. | Immunology | DFC |
| Jun 16, 26 | K253137510(k) | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Fujifilm Corporation | Ear, Nose, Throat | EOQ |
| Jun 16, 26 | K253159510(k) | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | Orthopedic | HSN |
| Jun 16, 26 | K253231510(k) | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) | Hubei Yjt Technology Co.,Ltd | Physical Medicine | OAP |
| Jun 16, 26 | K253264510(k) | myAblation Guide (VC10A) | Siemens Healthcare GmbH | Radiology | QTZ |
| Jun 16, 26 | K253374510(k) | LimiFlex® Dynamic Sagittal Tether Instrument Set | Empirical Spine | Orthopedic | SGL |
| Jun 16, 26 | K253723510(k) | BOSS | Medpark Co., Ltd. | Dental | NPM |
| Jun 16, 26 | K254025510(k) | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | General, Plastic Surgery | OHS |
| Jun 16, 26 | K260425510(k) | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Hivox Biotek, Inc. | Neurology | NUH |
| Jun 16, 26 | K260693510(k) | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | Cardiovascular | DXN |
| Jun 16, 26 | K260831510(k) | Z1 Hip System | Zimmer, Inc. | Orthopedic | LZO |
| Jun 16, 26 | K260844510(k) | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | Radiology | IYN |
| Jun 16, 26 | K260899510(k) | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | Zdeer Technology (Henan) Co., Ltd. | Physical Medicine | OAP |
| Jun 16, 26 | K260958510(k) | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH | Orthopedic | HRS |
| Jun 16, 26 | K261683510(k) | Augment Off-Axis Instrument System | Zimmer, Inc. | Orthopedic | PHX |
| Jun 16, 26 | K261833510(k) | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | General, Plastic Surgery | GEI |
| Jun 15, 26 | K253059510(k) | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | Cardiovascular | DXN |
| Jun 15, 26 | K253121510(k) | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | Gimbo Medical Technology Shenzhen Co., Ltd. | Obstetrics/Gynecology | MQE |
| Jun 15, 26 | K253151510(k) | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | Orthopedic | MAX |
| Jun 15, 26 | K253172510(k) | MediAI-OA | Crescom Co., Ltd. | Radiology | QIH |
| Jun 15, 26 | K253690510(k) | LungMaps | Siemens Healthineers AG | Radiology | QIH |
| Jun 15, 26 | K253825510(k) | Saige-Dx | DeepHealth, Inc. | Radiology | QDQ |
| Jun 15, 26 | K253922510(k) | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | Dental | NHA |
| Jun 15, 26 | K260036510(k) | NeckTune 3D SA Cervical Cage | Medyssey Co, Ltd. | Orthopedic | OVE |
| Jun 15, 26 | K260126510(k) | Curajel Oral Gel | USpharma, Ltd. | Unknown | OLR |
| Jun 15, 26 | K260286510(k) | Dynamo Spinal Cement; Salvo® Spine System | Spine Wave, Inc. | Orthopedic | PML |
| Jun 15, 26 | K260300510(k) | WatchMate Software | Anumana, Inc. | Radiology | QIH |
| Jun 15, 26 | K260333510(k) | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diasorin Molecular, LLC | Microbiology | PGX |
| Jun 15, 26 | K260335510(k) | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | Physical Medicine | ITI |
| Jun 15, 26 | K260452510(k) | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) | Zdeer Technology (Henan) Co., Ltd. | Ear, Nose, Throat | LXB |
| Jun 15, 26 | K260482510(k) | DRE Duo | Jpi Healthcare Co, Ltd. | Radiology | KPR |
| Jun 15, 26 | K260885510(k) | VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited | Unknown | |
| Jun 15, 26 | K261265510(k) | Permatage XT Settable Bone Putty | Orthocon, Inc. | Neurology | GXP |
| Jun 13, 26 | K261604510(k) | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | Neurology | GWQ |
| Jun 12, 26 | K252171510(k) | Barbed PDO Suture | Sutura Medical Technology, Inc. | General, Plastic Surgery | NEW |
| Jun 12, 26 | K252323510(k) | cobas pulse blood glucose monitoring system | Roche Diagnostics | Clinical Chemistry | PZI |
| Jun 12, 26 | K252932510(k) | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | Microbiology | QOF |
| Jun 12, 26 | K252933510(k) | DYNE PORT | Dyne Medical Group, Inc. | Gastroenterology, Urology | ODC |
| Jun 12, 26 | K252937510(k) | ThinkQA 3 | Dosisoft SA | Radiology | IYE |
| Jun 12, 26 | K252963510(k) | BTL-899TT | BTL Industries, Inc. | Physical Medicine | IMJ |
| Jun 12, 26 | K252987510(k) | ADRx Admixture Device | Epic Medical Pte. , Ltd. | General Hospital | LHI |
| Jun 12, 26 | K252996510(k) | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | Radiology | MQB |
| Jun 12, 26 | K253015510(k) | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. | Neurology | OLU |
| Jun 12, 26 | K253088510(k) | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | Cardiovascular | DQK |
| Jun 12, 26 | K253196510(k) | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | Cardiovascular | MWI |
| Jun 12, 26 | K253437510(k) | Spiro-VISTA | Spiro Robotics | Anesthesiology | BTR |
| Jun 12, 26 | K253688510(k) | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | General Hospital | PQH |
| Jun 12, 26 | K260102510(k) | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Stryker Corporation (Tornier, Inc.) | Orthopedic | PHX |
| Jun 12, 26 | K260346510(k) | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited | Obstetrics/Gynecology | HGX |
| Jun 12, 26 | K260406510(k) | Brainomix 360 Hyperdensity | Brainomix Limited | Radiology | QIH |
| Jun 12, 26 | K260514510(k) | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | General Hospital | FMF |
| Jun 12, 26 | K260635510(k) | HARBOR Occlusion Device | Nuvascular, Inc. | Cardiovascular | KRD |
| Jun 12, 26 | K260935510(k) | Stelo Glucose Biosensor System | Dexcom, Inc. | Clinical Chemistry | SBH |
| Jun 12, 26 | K261175510(k) | WHILL (WHILL Model C2) | Whill, Inc. | Physical Medicine | ITI |
| Jun 12, 26 | K261204510(k) | Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. | General, Plastic Surgery | ONF |
| Jun 12, 26 | K261207510(k) | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | Orthopedic | HRS |
| Jun 12, 26 | K261213510(k) | Medical Monitor (40HT513D) | Lg Electronics.Inc | Radiology | PGY |
| Jun 12, 26 | K261366510(k) | Virtus | Somnomed, Inc. | Dental | LRK |
| Jun 12, 26 | K261634510(k) | Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. | General, Plastic Surgery | QRK |
| Jun 12, 26 | P250021PMA | saypha® ChiQ | Croma-Pharma GmbH | General, Plastic Surgery | LMH |
| Jun 12, 26 | P250031PMA | VENTANA PTEN (SP218) RxDx Assay | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Pathology | SHF |
| Jun 11, 26 | K250129510(k) | AViTA Breast Pump | Avita Corporation | Obstetrics/Gynecology | HGX |
| Jun 11, 26 | K250839510(k) | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | Radiology | OAS |
| Jun 11, 26 | K251326510(k) | Respiration Rate algorithm | Edwards Lifesciences, LLC | Anesthesiology | BZQ |
| Jun 11, 26 | K253051510(k) | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. | Clinical Chemistry | MMI |
| Jun 11, 26 | K253052510(k) | Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. | Dental | LBH |
| Jun 11, 26 | K253607510(k) | UNEEG EpiSight System | Uneeg Medical A/S | Neurology | SEM |
| Jun 11, 26 | K253650510(k) | Anura Mobile Core SDK (M1) | Nuralogix Corporation | Cardiovascular | QME |
| Jun 11, 26 | K254087510(k) | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC | Orthopedic | KTT |
| Jun 11, 26 | K254145510(k) | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC | Dental | NHA |
| Jun 11, 26 | K260174510(k) | PROBEAT-CR | Hitachi High-Tech Corp. | Radiology | LHN |
| Jun 11, 26 | K260322510(k) | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | Radiology | QIH |
| Jun 11, 26 | K260653510(k) | Dexter L6 System | Distalmotion SA | General, Plastic Surgery | SDD |
| Jun 11, 26 | K260710510(k) | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. | Gastroenterology, Urology | GCJ |
| Jun 11, 26 | K260849510(k) | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | Physical Medicine | IOR |
| Jun 11, 26 | K260859510(k) | Rosetta SM, Rosetta SP | Hass Corp. | Dental | EIH |
| Jun 11, 26 | K261209510(k) | Ion-L | SurGenTec, LLC | Unknown | MRW |
| Jun 11, 26 | K261251510(k) | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | Dental | LRK |
| Jun 11, 26 | K261256510(k) | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | Ear, Nose, Throat | LXB |
| Jun 11, 26 | K261292510(k) | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | Obstetrics/Gynecology | NUC |
| Jun 11, 26 | K261610510(k) | Verge Microcatheter | Instylla, Inc. | Cardiovascular | KRA |
| Jun 10, 26 | K250690510(k) | Penumbra System (Thunderbolt Aspiration Tubing) | Penumbra, Inc. | Cardiovascular | NRY |
| Jun 10, 26 | K253115510(k) | LARS ACJ | Movmedix S.A.S. | Orthopedic | HTN |
| Jun 10, 26 | K253192510(k) | DeepXray Spina | Alpha Intelligence Manifolds, Inc. | Radiology | SAO |
| Jun 10, 26 | K253919510(k) | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | Physical Medicine | IRP |
| Jun 10, 26 | K254121510(k) | Colli-PeeDx Urine Collection Kit | DNA Genotek, Inc. | Microbiology | SIH |
| Jun 10, 26 | K260414510(k) | Tech-Image Video Endoscope System | Tech-Image CO., LTD. | Gastroenterology, Urology | GCJ |
| Jun 10, 26 | K260614510(k) | Tinnitus Therapy | Sivantos GmbH | Ear, Nose, Throat | KLW |
| Jun 10, 26 | K260810510(k) | Anteralign LS coverplate | Tyber Medical, LLC | Orthopedic | OVD |
| Jun 10, 26 | K260855510(k) | Profoject Safety Pen Needles | CMT Health PTE., Ltd. | General Hospital | FMI |
| Jun 10, 26 | K261016510(k) | MSS - Humeral reverse liners extension | Medacta International, SA | Orthopedic | PHX |
| Jun 10, 26 | K261174510(k) | RxSight® Insertion Device | Rxsight, Inc. | Ophthalmic | MSS |
| Jun 10, 26 | K261329510(k) | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical | Cardiovascular | DQK |
| Jun 9, 26 | K251251510(k) | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | Orthopedic | NKB |
| Jun 9, 26 | K252914510(k) | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare , Ltd. | Obstetrics/Gynecology | NUC |
| Jun 9, 26 | K253165510(k) | LAP-iX2N | Sejong Medical Co., Ltd. | General, Plastic Surgery | GEI |
| Jun 9, 26 | K260564510(k) | DESS Dental Smart Solutions | Terrats Medical SL | Dental | NHA |
| Jun 9, 26 | K260748510(k) | ES-Series | E-Scopics | Radiology | IYN |
| Jun 9, 26 | K260802510(k) | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | Orthopedic | QHE |
| Jun 9, 26 | K260864510(k) | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Jun 9, 26 | K261549510(k) | BOBBY Balloon Guide Catheter | MicroVention, Inc., d/b/a Terumo Neuro | Cardiovascular | QJP |
| Jun 9, 26 | K261621510(k) | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | General, Plastic Surgery | QUW |
| Jun 9, 26 | K261806510(k) | ERBECRYO 2 Cryosurgical Unit and Accessories | Erbe Elektromedizin GmbH | General, Plastic Surgery | GEH |
| Jun 8, 26 | K251944510(k) | Lipocosm Harmonic System | Lipocosm, LLC | General, Plastic Surgery | QPB |
| Jun 8, 26 | K253066510(k) | ELEOS with NanoCept® Technology Limb Salvage System | Onkos Surgical, Inc. | Orthopedic | QZZ |
| Jun 8, 26 | K253257510(k) | Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. | Physical Medicine | INI |
| Jun 8, 26 | K253542510(k) | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | Physical Medicine | IPF |
| Jun 8, 26 | K260332510(k) | EchoNext | Pathwai, Inc. | Cardiovascular | QXO |
| Jun 8, 26 | K261352510(k) | 2D Hip Planning Software | One Ortho | Radiology | LLZ |
| Jun 8, 26 | K261402510(k) | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | Clinical Chemistry | QBJ |
| Jun 5, 26 | K243192510(k) | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | Orthopedic | LPH |
| Jun 5, 26 | K251684510(k) | Alma TED+ System | Alma Lasers, Inc. | Physical Medicine | OAP |
| Jun 5, 26 | K253108510(k) | VEOFIX Snap Off Screw | Steps Ortho | Orthopedic | HWC |
| Jun 5, 26 | K253162510(k) | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. | General Hospital | FLL |
| Jun 5, 26 | K253204510(k) | Catalyze | BioTissue Holdings, Inc. | Unknown | KGN |
| Jun 5, 26 | K253296510(k) | Digital C-ARM with 3D | Allengers Medical Systems Limited | Radiology | OXO |
| Jun 5, 26 | K253656510(k) | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | General, Plastic Surgery | GEI |
| Jun 5, 26 | K254086510(k) | EyeBOX SNAP | Oculogica, Inc. | Neurology | QEA |
| Jun 5, 26 | K260056510(k) | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Physical Medicine | ITI |
| Jun 5, 26 | K260105510(k) | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Edwards Lifesciences | Cardiovascular | DXC |
| Jun 5, 26 | K260289510(k) | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | Cardiovascular | DQY |
| Jun 5, 26 | K260301510(k) | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | General Hospital | LHI |
| Jun 5, 26 | K260754510(k) | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | Assure Tech., LLC | Microbiology | QYT |
| Jun 5, 26 | K260761510(k) | APTUS Clavicle System 2.8 | Medartis AG | Orthopedic | HRS |
| Jun 5, 26 | K261492510(k) | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | Cardiovascular | DYB |
| Jun 5, 26 | P230038PMA | AbsorbaSeal 5.6.7F Vascular Closure Device | Cyndrx, LLC | Cardiovascular | MGB |
| Jun 4, 26 | K252575510(k) | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | New York Embroidery Studio (NYES) | General, Plastic Surgery | FYA |
| Jun 4, 26 | K253004510(k) | LUNA 3D | Lap GmbH Laser Applikationen | Radiology | IYE |
| Jun 4, 26 | K253020510(k) | Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | Obstetrics/Gynecology | HIH |
| Jun 4, 26 | K253026510(k) | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | Radiology | JAK |
| Jun 4, 26 | K253102510(k) | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | General, Plastic Surgery | SAH |
| Jun 4, 26 | K253553510(k) | Orion | Resmed Corp | Anesthesiology | BZD |
| Jun 4, 26 | K253602510(k) | Precision S 4K Sinuscope | Stryker Endoscopy | Neurology | GWG |
| Jun 4, 26 | K253893510(k) | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | Radiology | NFJ |
| Jun 4, 26 | K253984510(k) | Instrument Exit Point on Touch Surgery Aide | Covidien, LLC | Gastroenterology, Urology | SFE |
| Jun 4, 26 | K253994510(k) | TroKit Laparoscope Lens Wiper | TroCare, LLC | Gastroenterology, Urology | GCJ |
| Jun 4, 26 | K254209510(k) | Radius VSM and Accessories | Masimo Corporation | Cardiovascular | MHX |
| Jun 4, 26 | K260497510(k) | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | Radiology | QIH |
| Jun 4, 26 | K260662510(k) | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | Radiology | OAS |
| Jun 4, 26 | K260690510(k) | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | General, Plastic Surgery | GEX |
| Jun 4, 26 | K260770510(k) | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | DiaSorin, Inc. | Microbiology | LOM |
| Jun 4, 26 | K260956510(k) | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | Obstetrics/Gynecology | HGX |
| Jun 4, 26 | K261510510(k) | Signature ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | Orthopedic | QHE |
| Jun 4, 26 | K261519510(k) | Sonio Suspect | Sonio | Radiology | POK |
| Jun 3, 26 | K252800510(k) | KARL STORZ Endoscopic Accessories for Urology | Karl Storz SE & CO. KG | Gastroenterology, Urology | OCZ |
| Jun 3, 26 | K252854510(k) | SteriTite Container System with MediTray Products | Case Medical, Inc. | General Hospital | KCT |
| Jun 3, 26 | K252904510(k) | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | Dental | NHA |
| Jun 3, 26 | K253124510(k) | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | Cardiovascular | DXN |
| Jun 3, 26 | K253600510(k) | Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. | Physical Medicine | INI |
| Jun 3, 26 | K253974510(k) | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | Unknown | KGN |
| Jun 3, 26 | K254034510(k) | Roosin Collagen Powder | Roosin Medical Co., Ltd. | Unknown | KGN |
| Jun 3, 26 | K260116510(k) | CustoMED Viewer | CustoMED , Ltd. | Radiology | LLZ |
| Jun 3, 26 | K260179510(k) | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Neurology | NFO |
| Jun 3, 26 | K260373510(k) | Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | Physical Medicine | ITI |
| Jun 3, 26 | K260402510(k) | MeRT System | Wave Neuroscience | Neurology | SIG |
| Jun 3, 26 | K260703510(k) | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | General Hospital | LZA |
| Jun 3, 26 | K260715510(k) | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | General, Plastic Surgery | OHS |
| Jun 3, 26 | K260726510(k) | Straumann® ProClean Cassette (041.800 ; 041.801) | Institut Straumann AG | General Hospital | KCT |
| Jun 3, 26 | K260780510(k) | HeartFocus | Deski | Radiology | QJU |
| Jun 3, 26 | K260806510(k) | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | General Hospital | LZA |
| Jun 3, 26 | K261439510(k) | Permatage Flowable, Settable Hemostatic Bone Paste | Orthocon, Inc. | Unknown | MTJ |
| Jun 3, 26 | K261484510(k) | Tissue Approximation System | Tas Medical, Inc. | General, Plastic Surgery | GAR |
| Jun 3, 26 | K261522510(k) | BioWave BioWraps | Biowave Corporation | Neurology | GXY |
| Jun 3, 26 | K261530510(k) | iiSure Infusion Set | Deka Research and Development | General Hospital | FPA |
| Jun 3, 26 | K261826510(k) | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | Dental | DZJ |
| Jun 3, 26 | K261840510(k) | BracePaste Prime Plus | American Orthodontics | Dental | DYH |
| Jun 2, 26 | K252532510(k) | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | Gastroenterology, Urology | GCJ |
| Jun 2, 26 | K252816510(k) | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | Physical Medicine | IPF |
| Jun 2, 26 | K252844510(k) | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | Anesthesiology | PHZ |
| Jun 2, 26 | K252899510(k) | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | Clinical Chemistry | JKA |
| Jun 2, 26 | K253195510(k) | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | ZheJiang Decans Medical Devices Co., Ltd. | Orthopedic | NKG |
| Jun 2, 26 | K253302510(k) | Hemospray Endoscopic Hemostat (HEMO-[X]) | Wilson-Cook Medical, Inc. | General, Plastic Surgery | QAU |
| Jun 2, 26 | K253507510(k) | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | Orthalign, Inc. | Neurology | ONN |
| Jun 2, 26 | K253803510(k) | MILAN System | Lumenis Be, Ltd. | General, Plastic Surgery | GEI |
| Jun 2, 26 | K253918510(k) | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | General, Plastic Surgery | GEI |
| Jun 2, 26 | K260270510(k) | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | Anesthesiology | CAF |
| Jun 2, 26 | K260364510(k) | Device 300419 Strip | Geistlich Pharma AG | Orthopedic | MQV |
| Jun 2, 26 | K260569510(k) | DB 4000 High Impact Denture Base | Carbon, Inc. | Dental | EBI |
| Jun 2, 26 | K260571510(k) | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | Neurology | OLO |
| Jun 2, 26 | K260642510(k) | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | Physical Medicine | IOR |
| Jun 2, 26 | K261002510(k) | Pectus Blu System | Biomet Microfixation | Orthopedic | HRS |
| Jun 2, 26 | K261093510(k) | DIAFIL | DiaDent Group International | Dental | EBF |
| Jun 2, 26 | K261540510(k) | Cube 4D Navigation System, VirtuEye Pro | Fiagon GmbH | Neurology | PGW |
| Jun 1, 26 | K253882510(k) | CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. | Microbiology | QVF |
| Jun 1, 26 | K260456510(k) | VI°Port Liver Preservation System | Traferox Technologies, Inc. | Gastroenterology, Urology | KDN |
| Jun 1, 26 | K261541510(k) | VisionAir Enhanced Stock Stent | VisionAir Solutions | General, Plastic Surgery | NWA |
August 2026
July 2026
June 2026
May 2026
April 2026
March 2026
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December 2025
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October 2025
September 2025
Source: FDA 510(k) and PMA databases via openFDA. PMA supplements are excluded.