| Single-use Flexible Bronchoscope (K261637): 510(k) cleared for Hunan Vathin Medical Instrument Co., Ltd. | Other | 510(k) | 2026-09-23 |
| Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris | Radiology | 510(k) | 2026-09-23 |
| Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc. | Clinical Chemistry | 510(k) | 2026-09-22 |
| BoneXpert (K262390): 510(k) cleared for Visiana | Radiology | 510(k) | 2026-09-22 |
| HipStudio Analysis (K262442): 510(k) cleared for Replasia BV | Radiology | 510(k) | 2026-09-22 |
| OtoCompanion (Version 1.0) (K261725): 510(k) cleared for Ironsides Medical, Inc. | Other | 510(k) | 2026-09-21 |
| Rapid Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc. | Radiology | 510(k) | 2026-09-21 |
| KARL STORZ TIPCAM1 Rubina (K262547): 510(k) cleared for KALR STORZ SE & Co. KG | Gastroenterology, Urology | 510(k) | 2026-09-21 |
| FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condom | Obstetrics/Gynecology | 510(k) | 2026-09-21 |
| Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. | Clinical Chemistry | 510(k) | 2026-09-21 |
| CrossFAST Integrated Microcatheter Advanced Delivery System (K262817): 510(k) cleared for Vantis Vascular, Inc. | Cardiovascular | 510(k) | 2026-09-18 |
| EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies | Orthopedic | 510(k) | 2026-09-18 |
| TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC | Dental | 510(k) | 2026-09-17 |
| Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R | General, Plastic Surgery | 510(k) | 2026-09-17 |
| Protégé EverFlex Self-expanding Peripheral Stent System (K262913): 510(k) cleared for Medtronic, Inc. | Gastroenterology, Urology | 510(k) | 2026-09-17 |
| SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K262877): 510(k) cleared for Olympus Surgical Technologies America | General, Plastic Surgery | 510(k) | 2026-09-16 |
| TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc. | Orthopedic | 510(k) | 2026-09-15 |
| CraniUS Plate (K262874): 510(k) cleared for CraniUS, LLC | Neurology | 510(k) | 2026-09-11 |
| Electric Scooter (FDB08, FDB08A, FDB12) (K261859): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd. | Other | 510(k) | 2026-09-19 |
| Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-09-18 |
| Biolinq Shine Autonomous Time-in-Range Microsensor (K262599): 510(k) cleared for Biolinq Incorporated | Clinical Chemistry | 510(k) | 2026-09-18 |
| Pathfinder Endoscope Overtube (K262262): 510(k) cleared for Neptune Medical, Inc. | Gastroenterology, Urology | 510(k) | 2026-09-18 |
| Elucid PlaqueIQ (K261855): 510(k) cleared for Elucid Bioimaging, Inc. | Radiology | 510(k) | 2026-09-18 |
| NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU Medical | General Hospital | 510(k) | 2026-09-18 |
| SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation | Ophthalmic | 510(k) | 2026-09-18 |
| EnSite X EP System (K261729): 510(k) cleared for Abbott Medical | Cardiovascular | 510(k) | 2026-09-17 |
| Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc. | Orthopedic | 510(k) | 2026-09-17 |
| Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd. | Ophthalmic | 510(k) | 2026-09-17 |
| LED Therapy Device (QLXY-01) (K261673): 510(k) cleared for Beijing Nubway S&T Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-09-17 |
| Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) (K261817): 510(k) cleared for Zhengzhou PZ Laser Slim Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-09-17 |
| Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE | General, Plastic Surgery | 510(k) | 2026-09-17 |
| FRAXION Spinal Fixation System (K262091): 510(k) cleared for Ortler Global Tibbi Gerecler Anonim Sirketi | Orthopedic | 510(k) | 2026-09-17 |
| Electric Wheelchair (K262054): 510(k) cleared for Yongkang Joymax Medical Technology Co., Ltd. | Other | 510(k) | 2026-09-16 |
| AerFrame Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC | Radiology | 510(k) | 2026-09-16 |
| EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | 510(k) | 2026-09-16 |
| X°Port Heart Preservation System (K261913): 510(k) cleared for Traferox Technologies, Inc. | Gastroenterology, Urology | 510(k) | 2026-09-16 |
| LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (K261370): 510(k) cleared for Guangdong Newdermo Biotech Co., Ltd. | Neurology | 510(k) | 2026-09-16 |
| ClearClub Impression Material (K261888): 510(k) cleared for ClearClub | Dental | 510(k) | 2026-09-16 |
| GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467): 510(k) cleared for Gt Metabolic Solutions, Inc. | General, Plastic Surgery | 510(k) | 2026-09-16 |
| Embrace Vision Neonatal MRI System (K261758): 510(k) cleared for Aspect Imaging, Ltd. | Radiology | 510(k) | 2026-09-16 |
| JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd. | Cardiovascular | 510(k) | 2026-09-16 |
| Multifunctional wheelchair (YJ-059) (K261919): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd. | Other | 510(k) | 2026-09-16 |
| Mouth Guard (K262559): 510(k) cleared for ChangSha ChuangDuoLe E-Commerce Co., Ltd. | Other | 510(k) | 2026-09-16 |
| Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc. | Neurology | 510(k) | 2026-09-16 |
| iOS CamAPS FX (K261896): 510(k) cleared for CamDiab | Clinical Chemistry | 510(k) | 2026-09-16 |
| Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400): 510(k) cleared for Ambu A/S | Gastroenterology, Urology | 510(k) | 2026-09-16 |
| SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A. | Radiology | 510(k) | 2026-09-15 |
| CVAC® Aspiration System (K261447): 510(k) cleared for Calyxo, Inc. | Gastroenterology, Urology | 510(k) | 2026-09-15 |
| Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677): 510(k) cleared for Aramis Global AI Consultancies, LLC | Radiology | 510(k) | 2026-09-15 |
| GMK Extension (K262057): 510(k) cleared for Medacta International SA | Orthopedic | 510(k) | 2026-09-15 |
| qCT Lung (v1.0) (K261517): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd. | Radiology | 510(k) | 2026-09-14 |
| BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163): 510(k) cleared for Becton Dickinson and Company | Microbiology | 510(k) | 2026-09-14 |
| RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology (K262193): 510(k) cleared for Xenix Medical | Orthopedic | 510(k) | 2026-09-14 |
| HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L | Cardiovascular | 510(k) | 2026-09-14 |
| Safety lancet (XL) (K262526): 510(k) cleared for Tianjin Huahong Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-09-13 |
| Digistat Care (K261287): 510(k) cleared for Ascom Ums Srl Unipersonale | Cardiovascular | 510(k) | 2026-09-12 |
| FINDER Flu A&B/SARS-CoV-2 Test (K261837): 510(k) cleared for Baebies, Inc. | Microbiology | 510(k) | 2026-09-11 |
| MICSI-PET (K261305): 510(k) cleared for Microstructure Imaging, Inc. | Radiology | 510(k) | 2026-09-11 |
| CuratOR EX2742 (K262397): 510(k) cleared for Eizo Corporation | Gastroenterology, Urology | 510(k) | 2026-09-11 |
| SpaceOAR Flex System (K262151): 510(k) cleared for Boston Scientific Corporation | Radiology | 510(k) | 2026-09-11 |
| ZBPro Diagnostic (Version 2.0) (K261580): 510(k) cleared for Zbeats, Inc. | Cardiovascular | 510(k) | 2026-09-11 |
| Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025): 510(k) cleared for INNO Holdings Inc. DBA Innovasis | Orthopedic | 510(k) | 2026-09-11 |
| KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory | Ophthalmic | 510(k) | 2026-09-11 |
| Mg OSTEOREVIVE;Mg OSTEOCRETE (K262230): 510(k) cleared for Bone Solutions, Inc. | Orthopedic | 510(k) | 2026-09-11 |