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
42241–42264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2013
CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS
K123967 · QBP
Catheter Connections, Inc.
General Hospital · 27d
Cleared Jan 18, 2013
INNESIS PEEK CAGE
K120464 · MAX
Bk Meditech, Co., Ltd.
Orthopedic · 338d
Cleared Jan 18, 2013
POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
K121592 · LZA
Tekmedic (M) Sdn Bhd
General Hospital · 232d
Cleared CT Jan 18, 2013
IVUE WITH NORMATIVE DATABASE
K121739 · HLI
Optovue, Inc.
Ophthalmic · 219d
Cleared CT Jan 18, 2013
CARDIAC VX
K121762 · LLZ
Ge Medical Systems, LLC
Radiology · 217d
Cleared Jan 18, 2013
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122310 · HRS
Skeletal Dynamics, LLC
Orthopedic · 170d
Cleared Jan 18, 2013
GENESIS
K122768 · JAA
Dornier Medtech America, Inc.
Radiology · 130d
Cleared Jan 18, 2013
XGEO GC80
K123098 · KPR
Samsung Electronics Co., Ltd.
Radiology · 108d
Cleared Jan 18, 2013
NEUROPACE BURR HOLE COVER MODEL 8110
K123163 · GXR
NeuroPace, Inc.
Neurology · 101d
Cleared Jan 18, 2013
CALIBER SPACERS
K123231 · MAX
Globus Medical, Inc.
Orthopedic · 94d
Cleared Jan 18, 2013
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
K123299 · GZB
St. Jude Medical Neuromodulation
Neurology · 87d
Cleared Jan 18, 2013
BD PEN NEEDLE
K123300 · FMI
Becton, Dickinson & CO
General Hospital · 87d
Cleared Jan 18, 2013
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
K123328 · LZA
Nitrilist Gloves Manufacturing Sdn Bhd
General Hospital · 88d
Cleared Jan 18, 2013
VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
K123813 · OBJ
Vasonova, Inc.
Cardiovascular · 38d
Cleared Jan 18, 2013
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
K123828 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 37d
Cleared Jan 18, 2013
SYNGO.VIA
K123920 · LLZ
Siemens AG Medical Solutions
Radiology · 29d
Cleared Jan 17, 2013
CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM
K102689 · HRS
Conventus Orthopaedics
Orthopedic · 853d
Cleared Jan 17, 2013
HERO I DENTAL IMPLANT SYSTEM
K121098 · DZE
Kj Meditech Co., Ltd.
Dental · 281d
Cleared Jan 17, 2013
FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR...
K121421 · ONW
Fresenius Medical Care North America,...
Gastroenterology & Urology · 248d
Cleared Jan 17, 2013
RESORB-X G
K121606 · GWO
KLS-Martin L.P.
Neurology · 230d
Cleared Jan 17, 2013
ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
K121929 · FRZ
Diacor, Inc.
Radiology · 199d
Cleared Jan 17, 2013
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM,...
K122132 · OMP
Molnlycke Health Care
General & Plastic Surgery · 183d
Cleared Jan 17, 2013
POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
K122408 · LZA
Hongye Plastic Products Co., Ltd.
General Hospital · 162d
Cleared Jan 17, 2013
CRUX VENA CAVA FILTER SYSTEM
K122585 · DTK
Crux Biomedical
Cardiovascular · 146d