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
70657–70680 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2003
ORTHOPHOS XG DS/CEPH
K033073 · EHD
Sirona Dental Systems GmbH
Radiology · 11d
Cleared Oct 10, 2003
KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
K033151 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Oct 10, 2003
HAC-12 AND HAC-30 HEAD ARRAY COIL
K033152 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Oct 10, 2003
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K033162 · JJY
Cliniqa Corporation
Chemistry · 10d
Cleared Oct 10, 2003
GE 0.2T SIGNA PROFILE/I MR SYSTEM
K033168 · LNH
General Electric Co.
Radiology · 10d
Cleared Oct 09, 2003
VELOPEX AQUACUT FLUID ABRASION UNIT
K024105 · KOJ
Velopex International, Inc.
Dental · 300d
Cleared Oct 09, 2003
EM PROBE, EM PAD
K024361 · ILY
Em Probe, Inc.
Physical Medicine · 283d
Cleared Oct 09, 2003
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 239d
Cleared Oct 09, 2003
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K031061 · MBH
Zimmer, Inc.
Orthopedic · 189d
Cleared Oct 09, 2003
CYNOSURE SMART FILE ND:YAG LASERS
K031125 · GEX
Cynosure, Inc.
General & Plastic Surgery · 183d
Cleared Oct 09, 2003
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K031265 · MNH
Spine Next SA
Orthopedic · 171d
Cleared Oct 09, 2003
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE...
K032138 · KLA
Medtronic Vascular
Gastroenterology & Urology · 90d
Cleared Oct 09, 2003
DESENS-IONOMER
K032175 · EMA
Milton Hodosh, M.D.
Dental · 85d
Cleared Oct 09, 2003
NBD DISPOSABLE RF CANNULAE
K032196 · GXI
New Business Development, LLC
Neurology · 83d
Cleared Oct 09, 2003
ACCOLADE-J HIP STEM SERIES
K032300 · MEH
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Oct 09, 2003
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES
K032357 · GEX
Lumenis, Inc.
General & Plastic Surgery · 71d
Cleared Oct 09, 2003
SONOMA ANTERIOR CERVICAL PLATE SYSTEM
K032368 · KWQ
Seaspine
Orthopedic · 69d
Cleared Oct 09, 2003
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
K032427 · JEC
Meridan Medical
Orthopedic · 64d
Cleared Oct 09, 2003
SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM
K032506 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 56d
Cleared Oct 09, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
K032581 · LPH
Howmedica Osteonics Corp.
Orthopedic · 49d
Cleared Oct 09, 2003
PORT CASSETTE
K032654 · IXK
Orex Computed Radiography, Ltd.
Radiology · 42d
Cleared Oct 09, 2003
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
K032700 · MQP
Blackstone Medical, Inc.
Orthopedic · 37d
Cleared Oct 09, 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724 · MUJ
Adac Laboratories
Radiology · 36d
Cleared Oct 09, 2003
MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
K032768 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 31d