Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
48457–48480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2011
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT...
K110131 · EBF
3M Espe Dental Products
Dental · 3d
Cleared Jan 20, 2011
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
K100585 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 324d
Cleared Jan 20, 2011
LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
K100610 · ONG
Lutronic Corporation
General & Plastic Surgery · 323d
Cleared Jan 20, 2011
EMERALD SPINAL SYSTEM
K101446 · MNH
Mazor Surgical Technologies , Ltd.
Orthopedic · 241d
Cleared Jan 20, 2011
MOBIUS ULTRASOUND IMAGING SYSTEM
K102153 · IYO
Mobisante, Inc.
Radiology · 174d
Cleared Jan 20, 2011
CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS
K102203 · DKZ
Chemtron Biotech, Inc.
Toxicology · 169d
Cleared Jan 20, 2011
ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
K102743 · HWE
Ortho Solutions Limited
Orthopedic · 120d
Cleared Jan 20, 2011
ELECYSYS SHBG
K102814 · CDZ
Roche Diagnostics
Chemistry · 114d
Cleared Jan 20, 2011
PCP/PC STETHOSCOPE
K102893 · DQD
Rnk Products, Inc.
Cardiovascular · 112d
Cleared Jan 20, 2011
TQ HBA1C GEN3
K102914 · LCP
Roche
Chemistry · 111d
Cleared Jan 20, 2011
VASCOPRESS SEQUENTIAL DVT PUMP
K102940 · JOW
Compression Therapy Concepts
Cardiovascular · 108d
Cleared Jan 20, 2011
MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE
K103017 · GEI
Mederi Therapeutics, Inc.
General & Plastic Surgery · 100d
Cleared Jan 20, 2011
DMC COMPOSITE 2
K103351 · EBF
Kerr Corporation
Dental · 65d
Cleared Jan 20, 2011
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
K103468 · DWA
Sorin Group Deutschland GmbH
Cardiovascular · 57d
Cleared Jan 20, 2011
QUANTA SYSTEM DUOLITE
K103539 · GEX
Quanta System Spa
General & Plastic Surgery · 49d
Cleared Jan 20, 2011
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
K103715 · DRS
Mirador Biomedical, Inc.
Cardiovascular · 30d
Cleared Jan 20, 2011
SORIN C5 SYSTEM
K103762 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 28d
Cleared Jan 20, 2011
TERASON T3200 ULTRASOUND SYSTEM
K110020 · ITX
Teratech Corp.
Radiology · 17d
Cleared Jan 19, 2011
STERILE SALINE SOLUTION
K102165 · LPN
Cachet Pharmaceuticals Pvt. , Ltd.
Ophthalmic · 170d
Cleared Jan 19, 2011
SP-FIX SPINOUS PROCESS FIXATION PLATE
K102195 · KWP
Globus Medical, Inc.
Orthopedic · 168d
Cleared Jan 19, 2011
R3 XLPE ANTEVERTED LINERS
K102370 · MBL
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared Jan 19, 2011
IO-FLEX CATHETER
K102594 · BSO
Baxano, Inc.
Anesthesiology · 132d
Cleared Jan 19, 2011
ALBOGRAFT VASCULAR PROSTHESIS
K103080 · MAL
LeMaitre Vascular, Inc.
Cardiovascular · 92d
Cleared Jan 19, 2011
CPS DIRECT SL II SLITTABLE OUTER CATHETER
K103250 · DQY
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 77d