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
26785–26808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2018
CAPILLARYS Hb A1c
K171861 · PDJ
Sebia
Chemistry · 230d
Cleared Feb 07, 2018
G-Beam Fusion Beaming System
K172698 · HWC
Orthofix Srl
Orthopedic · 153d
Cleared Feb 07, 2018
PicoSure Workstation
K173199 · GEX
Cynosure, Inc.
General & Plastic Surgery · 128d
Cleared Feb 07, 2018
PRESS DUO elite, PRESS DUO elite AG
K173450 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 93d
Cleared Feb 07, 2018
THP Hip Fracture Plating System
K173826 · JDO
Biomet, Inc.
Orthopedic · 51d
Cleared Feb 07, 2018
ACUSON X800 Diagnostic Ultrasound System
K180067 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Feb 06, 2018
Gammex PI Breach Detect Powder Free Surgical Glove
K171375 · KGO
Ansell Healthcare Products, LLC
General Hospital · 272d
Cleared Feb 06, 2018
AcQRef Introducer Sheath
K171557 · DYB
Acutus Medical, Inc.
Cardiovascular · 252d
Cleared Feb 06, 2018
Accula Flu A/Flu B Test
K171641 · OZE
Mesa Biotech, Inc.
Microbiology · 249d
Cleared Feb 06, 2018
eUnity
K172490 · LLZ
Client Outlook, Inc.
Radiology · 173d
Cleared Feb 06, 2018
Insight BD
K172832 · LLZ
Siemens Medi Cal Solutions, Inc.
Radiology · 140d
Cleared Feb 06, 2018
Acid Etchant
K172953 · KLE
American Orthodontics
Dental · 133d
Cleared Feb 06, 2018
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
K173528 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 83d
Cleared Feb 06, 2018
SeaSpine Mariner Pedicle Screw System
K173882 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 47d
Cleared Feb 05, 2018
Trans-anal Introducer
K171208 · FED
Visionsense, Ltd.
Gastroenterology & Urology · 286d
Cleared Feb 05, 2018
BETTERCARE PLATFORM - ADVANCED WEB CLIENT
K171361 · MWI
Better Care, S.L.
Cardiovascular · 272d
Cleared Feb 05, 2018
Flip Lube
K171516 · NUC
Imquest Biosciences, Inc.
Obstetrics & Gynecology · 257d
Cleared Feb 05, 2018
First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First...
K171695 · NFT
W.H.P.M., Inc.
Toxicology · 243d
Cleared Feb 05, 2018
Aquilex Fluid Control System AQL-100S
K172040 · HIG
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 215d
Cleared Feb 05, 2018
RS85 Diagnostic Ultrasound System
K173204 · IYN
Samsung Medison Co., Ltd.
Radiology · 126d
Cleared Feb 05, 2018
ProxiDiagnost N90
K173433 · OWB
Philips Medical Systems Dmc GmbH
Radiology · 95d
Cleared Feb 05, 2018
MFI-Cardiac
K173512 · LLZ
Multifunctional Imaging, LLC
Radiology · 84d
Cleared Feb 05, 2018
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter
K173672 · QEW
Inari Medical
Cardiovascular · 67d
Cleared Feb 05, 2018
DRX-Revolution Nano Mobile X-ray System
K173924 · IZL
Carestream Health, Inc.
Radiology · 41d