FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71617–71640 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2003
JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II
K031342 · ITI
Jason Marine Enterprises, Inc.
Physical Medicine · 73d
Cleared Jul 10, 2003
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
K031410 · LON
bioMerieux, Inc.
Microbiology · 66d
Cleared Jul 10, 2003
CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE,...
K031482 · GXH
Cryomedical Instruemts , Ltd.
Neurology · 59d
Cleared Jul 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML
K031530 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Jul 10, 2003
SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
K031716 · MQX
Asia-Med GmbH and CO KG
General Hospital · 37d
Cleared Jul 10, 2003
X-PROT DUO PORT
K032044 · LJT
C.R. Bard, Inc.
General Hospital · 8d
Cleared Jul 09, 2003
DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135,...
K030638 · FGE
Avantec Vascular Corp.
Gastroenterology & Urology · 131d
Cleared Jul 09, 2003
ENTERALITE INFINITY ENTERAL FEEDING PUMP
K031199 · LZH
Zevex Intl., Inc.
General Hospital · 86d
Cleared Jul 09, 2003
TELZUIT CARDIAC MONITORING SYSTEM
K031229 · DXH
Telzuit Technologies, Inc.
Cardiovascular · 82d
Cleared Jul 09, 2003
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824 · CHH
Roche Diagnostics Corp.
Chemistry · 26d
Cleared Jul 09, 2003
PROPHYPEARLS
K031868 · EFB
Kavo America
Dental · 22d
Cleared Jul 09, 2003
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
K031913 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 19d
Cleared Jul 09, 2003
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD...
K032040 · KFM
Dideco S.P.A.
Cardiovascular · 8d
Cleared Jul 08, 2003
NGT
K022558 · KNT
Medical Innovative Products
Gastroenterology & Urology · 340d
Cleared Jul 08, 2003
SUILE WOUND DRESSING
K022967 · FRO
Hedonist Biochemical Technologies...
General & Plastic Surgery · 305d
Cleared Jul 08, 2003
THE SUAD DEVICE
K023836 · LRK
Strong Dental, Inc.
Dental · 232d
Cleared Jul 08, 2003
INTRAOS 70
K031118 · EHD
Blue X Imaging Srl
Radiology · 91d
Cleared Jul 08, 2003
SEZ SAFETY SYRINGE
K031163 · MEG
Sez Corporation
General Hospital · 85d
Cleared Jul 08, 2003
CYNOSURE PHOTOLIGHT PL
K031258 · GEX
Cynosure, Inc.
General & Plastic Surgery · 78d
Cleared Jul 08, 2003
TERUMO SURGUARD 2 SAFETY NEEDLE
K031453 · FMI
Terumo Medical Corp.
General Hospital · 62d
Cleared Jul 08, 2003
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
K031555 · LXC
Synthes (Usa)
Orthopedic · 50d
Cleared Jul 08, 2003
CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)
K031690 · GEX
Cynosure, Inc.
General & Plastic Surgery · 36d
Cleared Jul 08, 2003
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
K031929 · LLZ
Wide Corporation
Radiology · 15d
Cleared Jul 07, 2003
RESPIRATORY HUMIDIFIER, MODEL MR850
K020332 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 522d