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
100777–100800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1995
HEPARIN CONTROL KIT
K943520 · KFF
American Bioproducts Co.
Hematology · 432d
Cleared Sep 26, 1995
GAS PLASMA STERILIZATION
K944538 · HRY
Depuy, Inc.
Orthopedic · 376d
Cleared Sep 26, 1995
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
K945511 · MPE
Physio-Control Corp.
Cardiovascular · 321d
Cleared Sep 26, 1995
BIPOLAR GENERATOR MODEL 2352
K945914 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 298d
Cleared Sep 26, 1995
THERATEST EL-ANA PROFILES TEST SYSTEM
K950716 · LJM
Theratest Laboratories, Inc.
Immunology · 238d
Cleared Sep 26, 1995
TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
K952674 · KPS
Elscint, Inc.
Radiology · 106d
Cleared Sep 26, 1995
SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER
K952885 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 95d
Cleared Sep 26, 1995
SILK*SKIN SCAR TREATMENT
K953420 · MDA
Silk*Skin Care Co.
General & Plastic Surgery · 78d
Cleared Sep 26, 1995
HOWMEDICA MAINSTAY ANCHOR
K953531 · JDR
Howmedica Corp.
Orthopedic · 61d
Cleared Sep 26, 1995
VACS TABLE, 9650
K953556 · IXR
U.S. Imaging Tables, Inc.
Radiology · 71d
Cleared Sep 26, 1995
SURGICAL C-ARM TABLE, 9610
K953557 · IXR
U.S. Imaging Tables, Inc.
Radiology · 71d
Cleared Sep 26, 1995
BARD VISILEX MESH 3 X 6
K953577 · FTL
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 57d
Cleared Sep 26, 1995
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
K953582 · IZO
Varian Canada, Inc.
Radiology · 56d
Cleared Sep 26, 1995
DISTENDING DIVERTICULOSCOPE
K953596 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 56d
Cleared Sep 26, 1995
AUKULYTE
K953610 · KPY
Aukland Medical Plastics, Inc.
Radiology · 55d
Cleared Sep 26, 1995
VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS
K953804 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 49d
Cleared Sep 26, 1995
SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM
K953994 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 33d
Cleared Sep 25, 1995
TWIN SILICONE CATHETER
K923691 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 1159d
Cleared Sep 25, 1995
MEDRAD SPECTRIS MR INJECTOR
K935668 · DXT
Medrad, Inc.
Cardiovascular · 668d
Cleared Sep 25, 1995
PERSHIELD CPR DEVICE
K940820 · CBP
Rabintex Industries, Ltd.
Anesthesiology · 580d
Cleared Sep 25, 1995
SPECTROLYSE ANTIPLASMIN KIT
K941752 · GGP
Biopool AB
Hematology · 535d
Cleared Sep 25, 1995
EBV-VCA IGM ELISA TEST STSTEM
K944449 · LSE
Zeus Scientific, Inc.
Microbiology · 378d
Cleared Sep 25, 1995
QBC ACCUTUBE
K945205 · GKZ
Becton Dickinson Diagnostic...
Hematology · 335d
Cleared Sep 25, 1995
MECTEST
K945207 · DIO
Meco Industries
Toxicology · 335d