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
36073–36096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2014
ONE Snare Endovascular Microsnare System
K142265 · MMX
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Nov 13, 2014
Shock Pulse-SE Lithotripsy System CYBERWAND II
K142428 · FEO
Cybersonics, Inc.
Gastroenterology & Urology · 76d
Cleared Nov 13, 2014
Barricade Embolization Coil System
K142513 · HCG
Blockade Medical
Neurology · 66d
Cleared Nov 13, 2014
Biomet Headless Compression and Twist-off Screws
K142658 · HWC
Biomet Manufacturing Corp
Orthopedic · 56d
Cleared Nov 12, 2014
HEALTH EXPERT ELCTRONIC STIMULATOR
K133929 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 324d
Cleared Nov 12, 2014
COMPOSITE ORTHODONTIC BRACKETS
K140807 · DYW
Ortho Specialties
Dental · 225d
Cleared Nov 12, 2014
HIOSSEN IMPLANT SYSTEM
K140934 · DZE
Hiossen, Inc.
Dental · 215d
Cleared Nov 12, 2014
ANT MODEL 1
K141038 · KXK
Advanced Nuclide Technologies, LLC
Radiology · 204d
Cleared Nov 12, 2014
DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS
K141457 · NHA
Dentium Co., Ltd.
Dental · 163d
Cleared Nov 12, 2014
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
K141571 · HSB
Orthofix Srl
Orthopedic · 153d
Cleared Nov 12, 2014
EIDON
K142047 · MYC
Centervue S.P.A.
Ophthalmic · 107d
Cleared Nov 12, 2014
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator...
K142301 · DRE
Cook Vascular, Inc.
Cardiovascular · 86d
Cleared Nov 12, 2014
AngioVac Cannula
K142593 · DWF
AngioDynamics, Inc.
Cardiovascular · 58d
Cleared Nov 12, 2014
Zimmer Plates and Screws (ZPS), Forte Screws
K142836 · HRS
Zimmer, Inc.
Orthopedic · 43d
Cleared Nov 12, 2014
neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
K142903 · GCJ
Neosurgical, Ltd.
General & Plastic Surgery · 37d
Cleared Nov 12, 2014
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
K143076 · PGY
Jvckenwood Corporation
Radiology · 16d
Cleared Nov 12, 2014
Coronis Fusion 4MP LED
K143157 · PGY
Barco N.V.
Radiology · 9d
Cleared Nov 10, 2014
YEESCOPE LARYNGOSCOPES
K140951 · CCW
Yeescope Pty. , Ltd.
Anesthesiology · 210d
Cleared Nov 10, 2014
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K140961 · KTT
Stryker Trauma AG
Orthopedic · 209d
Cleared Nov 10, 2014
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · FRG
Kimberly-Clark Corp.
General Hospital · 209d
Cleared Nov 10, 2014
DENALI 501CEMENT
K141503 · EMA
Denali Corporation
Dental · 157d
Cleared Nov 10, 2014
LEAF PATIENT MONITORING SYSTEM
K141877 · KMI
Leaf Healthcare, Inc.
General Hospital · 122d
Cleared Nov 07, 2014
PANTHEON ELECTROSTIMULATOR
K133980 · BWK
Pantheon Research
Neurology · 315d
Cleared Nov 07, 2014
CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4...
K140389 · FRO
Entrotech Life Sciences, Inc.
General & Plastic Surgery · 266d