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
48289–48312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2011
FLOWREST
K103316 · BTT
Vapotherm, Inc.
Anesthesiology · 90d
Cleared Feb 08, 2011
MEDICAL VISORS MV100
K103507 · LNH
Medical Visors, Inc.
Radiology · 71d
Cleared Feb 08, 2011
MED-LOK SAFETY NEEDLE
K103781 · MEG
Sta-Med, LLC
General Hospital · 43d
Cleared Feb 08, 2011
SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
K110069 · KTT
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Feb 08, 2011
DEFIBRILLATOR ANALYZER - DA-2006P
K110192 · DRL
Bc Group International, Inc.
Cardiovascular · 15d
Cleared Feb 08, 2011
DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
K110199 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 15d
Cleared Feb 08, 2011
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
K110202 · ITX
Fujifilm Medical System U.S.A., Inc.
Radiology · 15d
Cleared Feb 07, 2011
MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K082254 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 913d
Cleared Feb 07, 2011
QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
K082255 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 913d
Cleared Feb 07, 2011
CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
K101439 · BSZ
Codonics, Inc.
Anesthesiology · 259d
Cleared Feb 07, 2011
HAKKI URINARY CATHETER
K101900 · GBM
Hakki Medical Technologies, Inc.
Gastroenterology & Urology · 215d
Cleared Feb 07, 2011
LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
K102470 · GEI
Covidien, Formerly Valleylab,
General & Plastic Surgery · 161d
Cleared Feb 07, 2011
COROENT INTERLOCK SYSTEM
K102547 · OVE
Nuvasive, Inc.
Orthopedic · 157d
Cleared Feb 07, 2011
PERIOPATCH
K103054 · OLR
Izun Pharmaceuticals Corporation
General & Plastic Surgery · 115d
Cleared Feb 07, 2011
STRAIGHT HANDPIECE ADAPTER
K103158 · EGS
Angstrom Mfg., Inc.
Dental · 104d
Cleared Feb 07, 2011
VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE
K103173 · MQV
Orthovita, Inc.
Orthopedic · 102d
Cleared Feb 07, 2011
NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
K103192 · HAW
Ilumark GmbH
Neurology · 101d
Cleared Feb 07, 2011
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
K103373 · DIH
Beckman Coulter, Inc.
Toxicology · 82d
Cleared Feb 07, 2011
ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME...
K103474 · EBG
Micerium S.P.A.
Dental · 73d
Cleared Feb 07, 2011
MEDEOR MATRIX
K103787 · FTM
Kensey Nash Corp.
General & Plastic Surgery · 42d
Cleared Feb 07, 2011
5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
K110164 · MBI
Arthrocare Corp.
Orthopedic · 19d
Cleared Feb 04, 2011
BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA...
K093835 · FYA
Bam Corp., Ltd.
General Hospital · 416d
Cleared Feb 04, 2011
SPY INTRA-OPERATIVE IMAGING SYSTEM
K100371 · IZI
Novadaq Technologies, Inc.
Radiology · 357d
Cleared Feb 04, 2011
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
K101077 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 291d