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
86353–86376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1999
WAKO AUTOKIT LP(A)
K981446 · DFC
Wako Chemicals USA, Inc.
Chemistry · 321d
Cleared Mar 09, 1999
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW...
K982283 · BYE
Caradyne, Ltd.
Anesthesiology · 252d
Cleared Mar 09, 1999
GTI-PF4 ELISA
K983379 · LCO
Genetic Testing Institute
Hematology · 165d
Cleared Mar 09, 1999
MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE...
K984271 · DTZ
Medtronic Vascular
Cardiovascular · 99d
Cleared Mar 09, 1999
SYSTEM U3 FOR CEFUROXIME
K984491 · JWY
Ab Biodisk
Microbiology · 82d
Cleared Mar 09, 1999
SYSTEM U3 FOR CEPHALOTHIN
K984581 · JWY
Ab Biodisk
Microbiology · 76d
Cleared Mar 09, 1999
GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984608 · JTN
Oxoid , Ltd.
Microbiology · 71d
Cleared Mar 09, 1999
LC FLOWFILL
K990108 · EBF
S & C Polymer GmbH
Dental · 55d
Cleared Mar 09, 1999
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
K990282 · JJY
Bio-Rad
Chemistry · 39d
Cleared Mar 09, 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K990283 · LZA
Hartalega Sdn Bhd
General Hospital · 39d
Cleared Mar 09, 1999
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25
K990375 · IKT
Medtronic Functional Diagnostics A/S
Neurology · 29d
Cleared Mar 09, 1999
NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
K990453 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 25d
Cleared Mar 09, 1999
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514 · DTP
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Mar 09, 1999
OSOM CARD PREGNANCY TEST, MODEL 103
K990576 · LCX
Wyntek Diagnostics, Inc.
Chemistry · 14d
Cleared Mar 09, 1999
OSOM CARD II HCG-URINE TEST, MODEL 102
K990578 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 14d
Cleared Mar 08, 1999
CCS
K983105 · EJI
Dentsply Midwest
Dental · 185d
Cleared Mar 08, 1999
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
K983126 · FIP
Minntech Corp.
Gastroenterology & Urology · 181d
Cleared Mar 08, 1999
ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
K984394 · DQX
Guidant Corp.
Cardiovascular · 90d
Cleared Mar 08, 1999
RF
K990035 · DHR
Abbott Laboratories
Immunology · 61d
Cleared Mar 08, 1999
OPTIBOND SOLO PLUS
K990498 · KLE
Sybron Dental Specialties, Inc.
Dental · 19d
Cleared Mar 05, 1999
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
K980351 · LSR
Boston Biomedica, Inc.
Microbiology · 400d
Cleared Mar 05, 1999
AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300
K981702 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 295d
Cleared Mar 05, 1999
IMFAST
K982952 · LHN
Siemens Medical Solutions USA, Inc.
Radiology · 193d
Cleared Mar 05, 1999
RESTORE (AKA RE/STOR)
K983164 · MNG
Nebl, Inc.
Gastroenterology & Urology · 176d