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
49177–49200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2010
24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT...
K102110 · IOR
Foshan Shunde Jaeyong Hardware Co., Ltd.
Physical Medicine · 90d
Cleared Oct 26, 2010
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC...
K102420 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 62d
Cleared Oct 26, 2010
MULTI-LEAD TRIALING CABLE MODEL 355531
K102523 · GZB
Medtronic, Inc.
Neurology · 54d
Cleared Oct 26, 2010
TRULIGHT 5520 AND TRULIGHT 5320
K102758 · FSY
Trumpf Kreuzer Medizin Systeme GmbH +...
General & Plastic Surgery · 33d
Cleared Oct 26, 2010
PHTIP DISPOSABLE ISFET CATHETER
K102801 · FFX
E-Cath Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Oct 26, 2010
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K103010 · KKY
Howmedica Osteonics Corp., Dba...
General & Plastic Surgery · 14d
Cleared Oct 26, 2010
ECO-S
K103121 · EBC
Vericom Co., Ltd.
Dental · 4d
Cleared Oct 25, 2010
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
K101235 · GXR
Neos Surgery S.L
Neurology · 175d
Cleared Oct 25, 2010
INFINITI CYP2C19 ASSAY
K101683 · NTI
Autogenomics, Incorporated
Toxicology · 132d
Cleared Oct 23, 2010
NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
K093069 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 388d
Cleared Oct 22, 2010
VANGUARD 360 REVISION KNEE SYSTEM
K093293 · JWH
Biomet, Inc.
Orthopedic · 366d
Cleared Oct 22, 2010
SIRONA CAD/CAM SYSTEM
K100152 · NHA
Sirona Dental Systems GmbH
Dental · 276d
Cleared Oct 22, 2010
DENTACENTER/EXPEDITION, MODEL SAF-430
K100212 · EIA
Safari Dental, Inc.
Dental · 270d
Cleared Oct 22, 2010
DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S
K100248 · KIF
Drfp , Ltd.
Dental · 268d
Cleared Oct 22, 2010
INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000
K100660 · FLL
Innochips Technology Co., Ltd.
General Hospital · 228d
Cleared Oct 22, 2010
CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140
K100744 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 220d
Cleared Oct 22, 2010
CLAVICLE LOCKING PLATE SYSTEM
K100944 · HRS
Newclip Technics
Orthopedic · 199d
Cleared Oct 22, 2010
PIONEER SPINOUS PROCESS FUSION PLATE
K101525 · KWP
Pioneer Surgical Technology
Orthopedic · 142d
Cleared Oct 22, 2010
ARTHREX PUSHLOCK ANCHORS
K101679 · MAI
Arthrex, Inc.
Orthopedic · 129d
Cleared Oct 22, 2010
QUANTUM RING FIXATION SYSTEM MODEL ISF
K101759 · KTT
Quantum Medical Concepts, LLC
Orthopedic · 121d
Cleared Oct 22, 2010
KYPHON ANCHOR FACET SCREW SYSTEM
K101765 · MRW
Medtronic Spine, LLC
Orthopedic · 121d
Cleared Oct 22, 2010
KANEKA PHARMA AMERICA XPRESS-WAY RX
K101839 · QEZ
Kaneka Pharma America, LLC
Cardiovascular · 113d
Cleared Oct 22, 2010
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS...
K101921 · CEW
Ortho-Clinical Diagnostics
Chemistry · 105d
Cleared Oct 22, 2010
XPRESS BALLOON DEVICE
K102003 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 99d