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
71737–71760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 28, 2003
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K031028 · JEY
Bioplate, Inc.
Dental · 27d
Cleared Apr 28, 2003
ORTHOPEDIC WIRE
K031127 · JDR
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Apr 25, 2003
APNEACHECK
K022294 · MNR
Im Systems
Anesthesiology · 283d
Cleared Apr 25, 2003
TRAVELSOME STANDARD
K030233 · CAW
Sim Italia S.R.L.
Anesthesiology · 92d
Cleared Apr 25, 2003
FLAT PANEL DISPLAY, ME183L
K030272 · LLZ
Totoku Electric Co., Ltd.
Radiology · 88d
Cleared Apr 25, 2003
MEDICAL FLAT PANEL DISPLAY, ME315L
K030274 · LLZ
Totoku Electric Co., Ltd.
Radiology · 88d
Cleared Apr 25, 2003
FLAT PANEL DISPLAYS, CDL SERIES
K030276 · LLZ
Totoku Electric Co., Ltd.
Radiology · 88d
Cleared Apr 25, 2003
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
K030353 · OKS
Eagle Vision, Inc.
Ophthalmic · 81d
Cleared Apr 25, 2003
BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60,...
K030959 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 29d