FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
84625–84648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 03, 1999
STECO-TITANMAGNETICS
K990979 · EGG
Steco-System-Technik GmbH & Cokg
Dental · 164d
Cleared Sep 03, 1999
PRISMATHERM II, ASTOLINE
K991159 · BSB
Stihler Electronic GmbH
Hematology · 149d
Cleared Sep 03, 1999
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
K991180 · LSR
Zeus Scientific, Inc.
Microbiology · 148d
Cleared Sep 03, 1999
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
K991185 · LSR
Zeus Scientific, Inc.
Microbiology · 148d
Cleared Sep 03, 1999
MUMPS IGG ELISA TEST SYSTEM
K991274 · LJY
Columbia Bioscience, Inc.
Microbiology · 143d
Cleared Sep 03, 1999
LIFEPAK 12 BIPHASIC
K991910 · MKJ
Physio-Control Corp.
Cardiovascular · 88d
Cleared Sep 03, 1999
MODULAR RADIAL HEAD
K991915 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Sep 03, 1999
ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L
K991946 · EIA
Sterilex Corp.
Dental · 86d
Cleared Sep 03, 1999
THE NOMOS CHANE II
K991966 · IYE
Nomos Corp.
Radiology · 85d