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
72241–72264 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K030415 · LJS
AngioDynamics, Inc.
General Hospital · 82d
Cleared Apr 30, 2003
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
K030451 · FBK
Carbon Medical Technologies, Inc.
Gastroenterology & Urology · 78d
Cleared Apr 30, 2003
CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS
K030690 · LMC
Codonics, Inc.
Radiology · 56d
Cleared Apr 30, 2003
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
K031185 · FRN
Abbott Laboratories
General Hospital · 15d
Cleared Apr 30, 2003
AQUASENS FLUID MONITORING SYSTEM
K031213 · HIG
Davol, Inc.
Obstetrics & Gynecology · 13d
Cleared Apr 29, 2003
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K020418 · MEA
P.T. Greenleaf
General Hospital · 446d
Cleared Apr 29, 2003
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K020421 · MEA
Hennig Enterprises Europe Srl
General Hospital · 446d
Cleared Apr 29, 2003
CARBODISSECTING ENDOSCOPE
K020925 · DWX
Endo Surgical Devices, Inc.
Cardiovascular · 404d
Cleared Apr 29, 2003
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
K021174 · DSB
Imagyn Surgical
Cardiovascular · 382d
Cleared Apr 29, 2003
X O ODONTOSURGE 4
K023672 · EKZ
Xo Care A/S
Dental · 179d
Cleared Apr 29, 2003
SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE...
K030133 · EBF
Dentalez Group
Dental · 105d
Cleared Apr 29, 2003
FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC...
K030303 · GEH
Cryocath Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Apr 29, 2003
DEROYAL DRAPES, STERILE, NON-STERILE
K030365 · KKX
Deroyal Industries, Inc.
General Hospital · 84d
Cleared Apr 29, 2003
SYNCHRON SYSTEMS OPIATE REAGENT
K031002 · DJG
Beckman Coulter, Inc.
Toxicology · 29d
Cleared Apr 28, 2003
MICROALBUMIN REAGENT SET AND CALIBRATORS
K023860 · DDZ
Pointe Scientific, Inc.,
Chemistry · 159d
Cleared Apr 28, 2003
CHROMOCHECK ANTITHROMBIN 25
K023991 · JBQ
Precision Biologic
Hematology · 146d
Cleared Apr 28, 2003
COZART EIA COCAINE ORAL FLIUD KIT
K030234 · DIO
Cozart Bioscience , Ltd.
Toxicology · 95d
Cleared Apr 28, 2003
FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128,...
K030297 · GXY
Enraf-Nonius, B.V.
Neurology · 90d
Cleared Apr 28, 2003
DEROYAL GOWNS, STERILE, NON-STERILE
K030364 · FYA
Deroyal Industries, Inc.
General Hospital · 83d
Cleared Apr 28, 2003
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
K030405 · LEG
Seradyn
Toxicology · 81d
Cleared Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
K030428 · DIP
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Apr 28, 2003
SCULPTING RESIN
K030585 · EBD
Bisco, Inc.
Dental · 63d
Cleared Apr 28, 2003
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
K030942 · JJY
Medical Analysis Systems, Inc.
Chemistry · 33d
Cleared Apr 28, 2003
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
K031009 · GWJ
Bio-Logic Systems Corp.
Neurology · 28d