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
31105–31128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2016
TEMPEDY
K152946 · NCX
Seiratherm GmbH
Neurology · 345d
Cleared Sep 15, 2016
PROW FUSION-L
K153665 · MAX
Nlt Spine, Ltd.
Orthopedic · 269d
Cleared Sep 15, 2016
HBOTC Muscle and Nerve Stimulator
K160255 · NUH
Hb Medical, Inc.
Neurology · 227d
Cleared Sep 15, 2016
Pledgeted COR-SUTURE QUICK LOAD
K160529 · GAW
Lsi Soultions
General & Plastic Surgery · 203d
Cleared Sep 15, 2016
Dentium Implantium & SuperLine Prosthetics
K160828 · NHA
Dentium Co., Ltd.
Dental · 174d
Cleared Sep 15, 2016
Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”,...
K161067 · QSZ
Engineered Tissue Solutions, LLC
General & Plastic Surgery · 153d
Cleared Sep 15, 2016
Compound W Wart Removal System Dual Power
K161294 · GEH
Medtech Products, Inc.
General & Plastic Surgery · 129d
Cleared Sep 15, 2016
Provicol QM Plus
K161630 · EMB
Voco GmbH
Dental · 94d
Cleared Sep 15, 2016
CARESCAPE Central Station V2
K162012 · DXJ
Ge Healthcare
Cardiovascular · 56d
Cleared Sep 15, 2016
Eusol-C
K162013 · LYX
Al.Chi.Mi.A. S.R.L
Ophthalmic · 56d
Cleared Sep 15, 2016
LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
K162047 · GEI
Covidien
General & Plastic Surgery · 52d
Cleared Sep 15, 2016
PhotonBlade
K162053 · GEI
Invuity, Inc.
General & Plastic Surgery · 52d
Cleared Sep 15, 2016
CORGRIP NG/NI Tube Retention System
K162110 · KNT
Corpak Medsystems, Inc. A Division of...
Gastroenterology & Urology · 48d
Cleared Sep 14, 2016
Flexitouch System
K153311 · PPS
Tactile Systems Technology, Inc. (Dba...
Cardiovascular · 302d
Cleared Sep 14, 2016
StealthStation System with Cranial Software
K153660 · HAW
Medtronic Navigation, Inc.
Neurology · 268d
Cleared Sep 14, 2016
OSTEON III
K153676 · LYC
Genoss Co., Ltd.
Dental · 268d
Cleared Sep 14, 2016
ACTICOAT Surgical Dressing
K153723 · FRO
Smith & Nephew Medical Limited
General & Plastic Surgery · 261d
Cleared Sep 14, 2016
Colposcope System
K160341 · HEX
Xuzhou Kernel Medical Equipment Co.,...
Obstetrics & Gynecology · 219d
Cleared Sep 14, 2016
CAM Titanium Blanks
K160784 · NHA
Altatec GmbH
Dental · 176d
Cleared Sep 14, 2016
SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K161081 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 149d
Cleared CT Sep 14, 2016
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and...
K161384 · PPN
Shockwave Medical, Inc.
Cardiovascular · 118d
Cleared Sep 14, 2016
Anexa Wound Flush, Sterile Water & Sterile Normal Saline
K161658 · FRO
Anexa Biomedical, Inc.
General & Plastic Surgery · 90d
Cleared Sep 14, 2016
GEM Premier 3000
K161818 · CGA
Instrumentation Laboratory CO
Chemistry · 75d
Cleared Sep 14, 2016
EBit Series Diagnostic Ultrasound System
K162172 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 42d