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
77041–77064 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2001
FOTONA DUALIS, FOTONA DUALIS PLUS
K011939 · GEX
Fotona D.D.
General & Plastic Surgery · 189d
Cleared Dec 27, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
K012183 · LGD
Bayer Diagnostics Corp.
Microbiology · 168d
Cleared Dec 27, 2001
BIOTEQUE VAGINAL PESSARIES
K013289 · HHW
Bioteque America, Inc.
Obstetrics & Gynecology · 86d
Cleared Dec 27, 2001
LONG TROCHANTERIC NAIL SYSTEM
K013563 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 62d
Cleared Dec 27, 2001
VICTORCH MEDITEK'S HCG TEST CARD
K013678 · DHA
Victorch Meditek, Inc.
Chemistry · 50d
Cleared Dec 27, 2001
VICTORCH HCG TEST STRIP
K013702 · JHI
Victorch Meditek, Inc.
Chemistry · 49d
Cleared Dec 27, 2001
D902 PH.I.S.I.O OXYGENATOR
K013915 · DTZ
Dideco S.P.A.
Cardiovascular · 30d
Cleared Dec 27, 2001
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR...
K013991 · JWH
Zimmer, Inc.
Orthopedic · 23d
Cleared Dec 27, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K014076 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 16d
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