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
76537–76560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 26, 2001
CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK...
K011589 · NCA
Bypass , Ltd.
General & Plastic Surgery · 217d
Cleared Dec 26, 2001
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K012731 · LPN
Ciba Vision Corporation
Ophthalmic · 133d
Cleared Dec 26, 2001
INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
K013225 · KMF
Medafor, Inc.
General & Plastic Surgery · 90d
Cleared Dec 26, 2001
OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES
K013445 · LPL
Florida Optical Engineering, Inc.
Ophthalmic · 70d
Cleared Dec 26, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
K013549 · DAP
Sigma Diagnostics, Inc.
Hematology · 63d
Cleared Dec 26, 2001
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
K013591 · EOB
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 57d
Cleared Dec 26, 2001
SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
K013649 · LPL
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 51d
Cleared Dec 21, 2001
VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
K011702 · NHI
Vertis Neuroscience, Inc.
Neurology · 203d
Cleared Dec 21, 2001
VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
K011832 · NMF
Vanguard Medical Concepts, Inc.
Cardiovascular · 192d
Cleared Dec 21, 2001
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · DQY
Boston Scientific Corp
Cardiovascular · 186d
Cleared Dec 21, 2001
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106
K011953 · CGA
Wiener Laboratories Saic
Chemistry · 183d
Cleared Dec 21, 2001
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR...
K011960 · GEX
Lares Research, Inc.
General & Plastic Surgery · 182d
Cleared Dec 21, 2001
DIGIPAN / DPI
K012514 · MUH
Trophy Radiologie
Radiology · 137d
Cleared Dec 21, 2001
MODIFICATION TO: INJECTABLE MIMIX
K012569 · GXP
Biomet, Inc.
Neurology · 134d
Cleared Dec 21, 2001
GELCLAIR CONCENTRATED ORAL GEL
K013056 · OLR
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 101d
Cleared Dec 21, 2001
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
K013193 · GEX
Biolitec, Inc.
General & Plastic Surgery · 88d
Cleared Dec 21, 2001
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
K013371 · JJQ
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 71d
Cleared Dec 21, 2001
NORMATEC PCD
K013436 · JOW
Normatec, Inc.
Cardiovascular · 66d
Cleared Dec 21, 2001
SPIFE 2000/3000 LIPOPROTEIN
K013466 · JHO
Helena Laboratories
Chemistry · 64d
Cleared Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482 · DJG
Roche Diagnostics Corp.
Toxicology · 63d
Cleared Dec 21, 2001
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
K013527 · HTO
Synthes (Usa)
Orthopedic · 59d
Cleared Dec 21, 2001
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K013568 · DHX
Bayer Corp.
Immunology · 56d
Cleared Dec 21, 2001
ACS 180 HOMOCYSTEINE ASSAY
K013606 · LPS
Bayer Diagnostics Corp.
Chemistry · 51d
Cleared Dec 21, 2001
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
K013628 · MSV
Diamedix Corp.
Immunology · 46d