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
19513–19536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2020
PNEUMOCLEAR
K201361 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 68d
Cleared Jul 29, 2020
Zoom 14 Guidewire
K201760 · DQX
Scientia Vascular, LLC
Neurology · 30d
Cleared Jul 28, 2020
AccelFix Lumbar Plate System
K192481 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 322d
Cleared Jul 28, 2020
Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein...
K192681 · FPA
Jiangsu Kangbao Medical Equipment...
General Hospital · 306d
Cleared Jul 28, 2020
Quantisal Oral Fluid Collection Device
K200801 · PJD
Immunalysis Corporation
Chemistry · 123d
Cleared Jul 28, 2020
Neocis Guidance System (NGS) with Patient Splints
K200805 · PLV
Neocis, Inc.
Dental · 123d
Cleared Jul 28, 2020
Connected OR Hub with Voice Control, Connected OR Hub with Device Control
K201434 · GCJ
Stryker
General & Plastic Surgery · 57d
Cleared Jul 28, 2020
SyMRI
K201616 · LNH
Syntheticmr AB
Radiology · 43d
Cleared Jul 28, 2020
TRUSELECT Microcatheter
K201792 · KRA
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Jul 28, 2020
Jade
K201794 · LIT
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 28d
Cleared Jul 27, 2020
StaClear Syringe
K200242 · QLY
Tribofilm Research, Inc.
General Hospital · 178d
Cleared Jul 27, 2020
Vitalograph Model 2120 In2itive eDiary
K200550 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 146d
Cleared Jul 27, 2020
Stratum™ Reduced Size Foot Plating System
K200785 · HRS
Nextremity Solutions, Inc.
Orthopedic · 123d
Cleared Jul 27, 2020
Arthrex Compression Screws
K201132 · HRS
Arthrex, Inc.
Orthopedic · 90d
Cleared Jul 27, 2020
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
K201280 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 75d
Cleared Jul 24, 2020
Extremely Thin 003, ZERO ZERO THREE
K192669 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 303d
Cleared Jul 24, 2020
Arthrex SutureTape
K193575 · GAT
Arthrex, Inc.
General & Plastic Surgery · 214d
Cleared Jul 24, 2020
Single Use Electrosurgical Knife
K193601 · GEI
Micro-Tech (Nanjing) Co., Ltd.
General & Plastic Surgery · 214d
Cleared Jul 24, 2020
Disposable Temperature Probe
K193625 · FLL
Shenzhen Changke Connect Electronics...
General Hospital · 211d
Cleared Jul 24, 2020
Aer X
K200496 · CAW
3B Medical, Inc.
Anesthesiology · 147d
Cleared Jul 24, 2020
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus...
K200643 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 135d
Cleared Jul 24, 2020
JUSHA-CP610 LCD Monitor
K200742 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 123d
Cleared Jul 24, 2020
Tempus LS - Manual
K200849 · LDD
Remote Diagnostic Technologies, Ltd....
Cardiovascular · 115d
Cleared Jul 24, 2020
Transept Cervical Plate System
K200927 · KWQ
Neurostructures, Inc.
Orthopedic · 108d