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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39673–39696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2013
MAXLOCK EXTREME SYSTEM
K132591 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 29d
Cleared Sep 17, 2013
CRYSTALSERT DELIVERY SYSTEM
K132593 · MSS
Bausch & Lomb
Ophthalmic · 29d
Cleared Sep 16, 2013
PNEUPAC PARAPAC PLUS
K123957 · BTL
Smiths Medical International , Ltd.
Anesthesiology · 269d
Cleared Sep 16, 2013
DEPUY CORAIL AMT HIP PROSTHESIS
K123991 · KWY
Depuy France S.A.S.
Orthopedic · 264d
Cleared Sep 16, 2013
ELECTROSURGICAL GENERATOR
K130760 · GEI
Beijing Jinhengwei Technology...
General & Plastic Surgery · 180d
Cleared Sep 16, 2013
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
K130802 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 178d
Cleared Sep 16, 2013
ERCHONIA EMERGE
K130996 · NHN
Erchonia Medical, Inc.
Physical Medicine · 159d
Cleared Sep 16, 2013
NOVOKNEE TOTAL KNEE SYSTEM
K131398 · JWH
Novosource, Inc.
Orthopedic · 124d
Cleared Sep 16, 2013
HEART SYNC
K131494 · MKJ
Heart Sync, Inc.
Cardiovascular · 116d
Cleared Sep 16, 2013
RAMPART-O, RAMPART-T
K132053 · MAX
Spineology, Inc.
Orthopedic · 75d
Cleared Sep 13, 2013
TANYX
K123866 · NUH
Medecell Us, Inc.
Neurology · 270d
Cleared Sep 13, 2013
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
K123902 · IKN
Oktx, LLC
Neurology · 269d
Cleared Sep 13, 2013
LOBSTER AUTO-INJECTOR
K124026 · KZH
Scandinavian Health Limited
General Hospital · 259d
Cleared Sep 13, 2013
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
K124031 · OWN
Intuitive Surgical, Inc.
General & Plastic Surgery · 259d
Cleared Sep 13, 2013
LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE
K130641 · OVD
Binder Biomedical, Inc.
Orthopedic · 186d
Cleared Sep 13, 2013
VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM
K130873 · PFH
Vital Access
Gastroenterology & Urology · 168d
Cleared Sep 13, 2013
PIONEER ELITE DIODE LASER
K131059 · GEX
CAO Group, Inc.
General & Plastic Surgery · 150d
Cleared Sep 13, 2013
SASMAR ORIGINAL, SASMAR CLASSIC
K131084 · NUC
Sasmar, Inc.
Obstetrics & Gynecology · 148d
Cleared Sep 13, 2013
CAS PSI KNEE SYSTEM
K131409 · JWH
Orthosoft, Inc.
Orthopedic · 121d
Cleared Sep 13, 2013
VYSIS D7S486/CEP 7 FISH PROBE KIT
K131508 · PFG
Abbott Molecular, Inc.
Pathology · 112d
Cleared Sep 13, 2013
CEROX
K131854 · DPW
Or-Nim Medical , Ltd.
Cardiovascular · 84d
Cleared Sep 13, 2013
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K132175 · DXC
Edwards Lifesciences, LLC
Cardiovascular · 60d
Cleared Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
K132249 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Sep 13, 2013
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
K132573 · LON
bioMerieux, Inc.
Microbiology · 28d