FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
28753–28776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Jun 22, 2017
EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z...
K171307 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 50d
Cleared Jun 22, 2017
CUBEScan™ BioCon-900 (Bladder Volume Measurement System)
K171591 · IYO
Mcube Technology Co., Ltd.
Radiology · 22d
Cleared Jun 22, 2017
AOS Anterolateral Proximal Humeral Plate
K171606 · KTW
Advanced Orthopaedic Solutions, Inc....
Orthopedic · 21d
Cleared Jun 21, 2017
Solution Set with 1.2 Micron Air Eliminating Filter
K161808 · FPA
Baxter Healthcare Corporation
General Hospital · 355d
Cleared Jun 21, 2017
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
K162737 · LON
bioMerieux, Inc.
Microbiology · 264d
Cleared Jun 21, 2017
GOLNIT Non-Absorbable PTFE Surgical Suture
K163049 · NBY
Antarma Dba Golnit Sutures
General & Plastic Surgery · 232d
Cleared Jun 21, 2017
Terrace™ Anterior Cervical Plate System
K163104 · KWQ
Corelink, LLC
Orthopedic · 226d
Cleared Jun 21, 2017
PRIMUS
K163195 · OBO
Carl Zeiss Suzhou Co., Ltd.
Ophthalmic · 218d
Cleared Jun 21, 2017
TVC Imaging System, TVC Catheter
K163345 · OGZ
Infraredx, Inc.
Cardiovascular · 204d
Cleared Jun 21, 2017
Biodesign Fistula Plug
K170016 · FTM
Cook Biotech Incorporated
General & Plastic Surgery · 169d
Cleared CT Jun 21, 2017
ImPACT Quick Test
K170551 · POM
Impact Applications, Inc.
Neurology · 117d
Cleared Jun 21, 2017
Retina Workplace
K170638 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 111d
Cleared Jun 21, 2017
Venue
K170714 · IYN
GE Medical Systems Ultrasound &...
Radiology · 104d
Cleared Jun 21, 2017
DRX-Revolution Nano Mobile X-ray System
K170755 · IZL
Carestream Health, Inc.
Radiology · 100d
Cleared Jun 21, 2017
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
K170864 · GGN
Maine Standards Company, LLC
Hematology · 90d
Cleared Jun 21, 2017
BSD4343R Digital Flat Panel X-ray Detector
K171485 · MQB
Bontech, Inc.
Radiology · 30d
Cleared Jun 20, 2017
COSMED K5 Wearable Metabolic Technology
K162515 · BZC
Cosmed Srl
Anesthesiology · 285d
Cleared Jun 20, 2017
Corin MetaFix Hip Stem
K162942 · LZO
Corin U.S.A. Limited
Orthopedic · 242d
Cleared Jun 20, 2017
Premium Plus Disposable Barrier Sleeve
K163447 · PEM
Premium Plus International Limited
Dental · 194d
Cleared Jun 20, 2017
Summit Spine Channel Cervical Interbody Fusion System
K163494 · ODP
Summit Spine
Orthopedic · 189d
Cleared Jun 20, 2017
Additive Orthopaedics Bunion System
K163593 · HRS
Additive Orthopaedics, LLC
Orthopedic · 181d
Cleared Jun 20, 2017
STERRAD VELOCITY Biological Indictator and Reader
K170039 · FRC
Advanced Sterilization Products (Asp)
General Hospital · 166d
Cleared Jun 20, 2017
Stryker SonicPin System
K170418 · HTY
Stryker Trauma GmbH
Orthopedic · 127d
Cleared Jun 20, 2017
Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
K170571 · HWC
Tyber Medical, LLC
Orthopedic · 113d