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
85129–85152 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1999
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
K992135 · LNH
Ge Medical Systems, Inc.
Radiology · 76d
Cleared Sep 08, 1999
ECHOCARDIOGRAPHY SYSTEM SERIES 95000
K992259 · LLZ
Camtronics, Ltd.
Radiology · 64d
Cleared Sep 08, 1999
MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
K992305 · ITX
Medi-Stim A/S
Radiology · 62d
Cleared Sep 08, 1999
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K992379 · JXG
Radionics, Inc.
Neurology · 54d
Cleared Sep 08, 1999
SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM
K992472 · GEX
Clinicon Corp.
General & Plastic Surgery · 44d
Cleared Sep 08, 1999
SLIMLINE SURGICAL CLAMP
K992640 · DXC
Minumys Surgical, Inc.
Cardiovascular · 33d
Cleared Sep 08, 1999
CYNOSURE DIODERM
K992765 · GEX
Cynosure, Inc.
General & Plastic Surgery · 22d
Cleared Sep 08, 1999
DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE
K992893 · EIA
Mrlb Intl., Inc.
Dental · 12d
Cleared Sep 08, 1999
IMPREGUM F
K992895 · ELW
Espe Dental AG
Dental · 12d
Cleared Sep 08, 1999
IMPREGUM PENTA
K992897 · ELW
Espe Dental AG
Dental · 12d
Cleared Sep 07, 1999
BIO-97
K991901 · EJT
Jeneric/Pentron, Inc.
Dental · 95d
Cleared Sep 07, 1999
N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K992170 · LZA
Best Manufacturing Company
General Hospital · 71d
Cleared Sep 07, 1999
QUANTITATIVE FLOW
K992225 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 67d
Cleared Sep 07, 1999
GENDEX 765DC, MODEL 110-0154
K992610 · EHD
Dentsply Intl.
Radiology · 34d
Cleared Sep 07, 1999
DENTAPURE DP40 CARTRIDGE
K992868 · EIA
Mrlb Intl., Inc.
Dental · 12d
Cleared Sep 03, 1999
SHINMED MODEL SW-966 ULTRASONIC NEBULIZER
K980024 · CAF
Shining World Health Care Co., Ltd.
Anesthesiology · 606d
Cleared Sep 03, 1999
FRESENIUS BLOOD VOLUME MONITOR
K982926 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 379d
Cleared Sep 03, 1999
FLEXIBLADE
K984101 · CCW
Arco Medic , Ltd.
Anesthesiology · 290d
Cleared Sep 03, 1999
THE LIBERATOR
K984391 · IPL
Liberator Wheelchairs, Inc.
Physical Medicine · 269d
Cleared Sep 03, 1999
STACKABLE CAGE SYSTEM
K990148 · MQP
Depuy Motech Acromed
Orthopedic · 227d
Cleared Sep 03, 1999
IS H. PYLORI IGG ELISA TEST SYSTEM
K990462 · LYR
Columbia Bioscience, Inc.
Microbiology · 203d
Cleared Sep 03, 1999
MODIFICATION OF NOGA
K990494 · DQK
Biosense, Inc.
Cardiovascular · 198d
Cleared Sep 03, 1999
ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
K990689 · LJE
Zcv ,Inc.
Gastroenterology & Urology · 184d
Cleared Sep 03, 1999
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K990762 · MKJ
Zoll Medical Corp
Cardiovascular · 179d