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
70153–70176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 09, 2003
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD...
K032789 · FRN
American I.V. Products, Inc.
General Hospital · 31d
Cleared Oct 09, 2003
US-100 PORTABLE ULTRASOUND THERAPY UNIT
K032793 · IMI
Ito Co., Ltd.
Physical Medicine · 30d
Cleared Oct 09, 2003
MAS PAR TDM
K032826 · DIF
Medical Analysis Systems, Inc.
Toxicology · 29d
Cleared Oct 09, 2003
UNOMEDICAL MONICA INFUSION SET
K032854 · FPA
Unomedical A/S
General Hospital · 27d
Cleared Oct 09, 2003
T2 RECON NAIL SYSTEM
K032898 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Oct 09, 2003
SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES
K033160 · JEY
Synthes (Usa)
Dental · 9d
Cleared Oct 08, 2003
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437 · JIL
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Oct 08, 2003
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING
K032605 · KIF
Meta Biomed Co., Ltd.
Dental · 44d
Cleared Oct 08, 2003
ENDOTINE FOREHEAD DEVICE
K032770 · HWC
Coapt Systems, Inc.
Orthopedic · 30d