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
75337–75360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2002
VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
K020576 · NIJ
Id Biomedical Corp.
Microbiology · 69d
Cleared May 01, 2002
GRIDLOCK 195 ADHESIVE
K020648 · DYH
Allodex Systems
Dental · 62d
Cleared May 01, 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073 · EOB
Olympus America, Inc.
Ear, Nose, Throat · 29d
Cleared May 01, 2002
OLYMPUS BF TYPE UM40
K021204 · PSV
Olympus Optical Co., Ltd.
Radiology · 15d
Cleared May 01, 2002
AROX 53-BP
K021217 · DTB
Biotronik, Inc.
Cardiovascular · 14d
Cleared Apr 30, 2002
PATTON TRIPOL
K012279 · GEI
Patton Medical Corp.
General & Plastic Surgery · 285d
Cleared Apr 30, 2002
GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
K020210 · NBW
Bayer Group Diagnostics
Chemistry · 98d
Cleared Apr 30, 2002
DIGI-PRO TENS, MODEL WL-2204 AND WL-2205
K020314 · IPF
Well-Life Healthcare, Inc.
Physical Medicine · 90d
Cleared Apr 30, 2002
BCI 3180 PULSE OXIMETER
K020350 · DQA
Bci, Inc.
Anesthesiology · 85d
Cleared Apr 30, 2002
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
K020366 · DPS
Cardiocomm Solutions, Inc.
Cardiovascular · 85d
Cleared Apr 30, 2002
EAV KINDLING 2000S GSR DEVICE
K020564 · GZO
Virbrant Health
Neurology · 69d
Cleared Apr 30, 2002
EAV COMBI-2
K020565 · GZO
Vibrant Health
Neurology · 69d
Cleared Apr 30, 2002
AKUPORT M-2
K020568 · GZO
Vibrant Health
Neurology · 69d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL -...
K020686 · JWY
Dade Microscan, Inc.
Microbiology · 57d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
K020691 · JWY
Dade Microscan, Inc.
Microbiology · 57d
Cleared Apr 30, 2002
DIGI-PRO TENS MODEL WL-2203 AND WL-2205
K021359 · GZJ
Well-Life Healthcare, Inc.
Neurology · 90d
Cleared Apr 29, 2002
REPROCESSED GUIDEWIRES
K012556 · NML
Sterilmed, Inc.
Gastroenterology & Urology · 264d
Cleared Apr 29, 2002
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
K013471 · LNS
E.S.W.L. Products, Inc.
Gastroenterology & Urology · 193d
Cleared Apr 29, 2002
GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
K020208 · NBW
Bayer Group Diagnostics
Chemistry · 97d
Cleared Apr 29, 2002
CLEARVIEW WRIST FIXATOR
K020311 · KTT
Rigid FX Orthopedics, Incorporated
Orthopedic · 90d
Cleared Apr 29, 2002
QUANTA LITE CCP ELISA
K020414 · NHX
Inova Diagnostics, Inc.
Immunology · 81d
Cleared Apr 29, 2002
EVANS SUB-Q, MODEL MC4206
K020530 · FPA
Evans Medical, Inc.
General Hospital · 69d
Cleared Apr 29, 2002
ETEST ERTAPENEM
K020748 · JWY
Ab Biodisk
Microbiology · 53d
Cleared Apr 29, 2002
CALIBRATING MATERIAL, CAL-PAK, BUFFERS
K020894 · JIT
Mission Diagnostics
Chemistry · 41d