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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
58057–58080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2007
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S)...
K071655 · DSI
Medtronic, Inc.
Cardiovascular · 156d
Cleared Nov 21, 2007
MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K071927 · NDN
Depuy Spine, A Johnson & Johnson Company
Orthopedic · 132d
Cleared Nov 21, 2007
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE...
K071958 · BTT
Smiths Medical Asd, Inc.
Anesthesiology · 128d
Cleared Nov 21, 2007
PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE
K072372 · JOW
Mego Afek
Cardiovascular · 90d
Cleared Nov 21, 2007
RT300-S AND RT300-SP FES CYCLE ERGOMETER
K072398 · GZI
Restorative Therapies, Inc.
Neurology · 86d
Cleared Nov 21, 2007
GENERATION 8 SE ADHESIVE
K072480 · KLE
Pentron Clinical Technologies
Dental · 78d
Cleared Nov 21, 2007
TWIN-PASS OTW CATHETER, MODEL 5201
K072618 · DQY
Vascular Solutions, Inc.
Cardiovascular · 65d
Cleared Nov 21, 2007
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF)...
K072619 · MBH
Zimmer, Inc.
Orthopedic · 65d
Cleared Nov 21, 2007
I LIGHT
K072807 · EBZ
Dent'N CO
Dental · 51d
Cleared Nov 21, 2007
MRI SYSTEM, MODEL MAGFINDER II / AI 3200
K072850 · LNH
Advanced Imaging Laboratory
Radiology · 48d
Cleared Nov 21, 2007
IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K
K072867 · KPR
Imix Adr Finland OY
Radiology · 47d
Cleared Nov 21, 2007
CTU676 DEVICE
K073013 · JOW
Compression Technologies Unlimited, Inc.
Cardiovascular · 27d
Cleared Nov 21, 2007
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
K073081 · LNH
Toshiba America Medical Systems, In.C
Radiology · 20d
Cleared Nov 21, 2007
ZENO ZR DISC
K073108 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 19d
Cleared Nov 21, 2007
MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE
K073122 · FMI
Covidien Lp, Formerly Registered AS...
General Hospital · 15d
Cleared Nov 21, 2007
VITALOGIK MODEL 4000/4500
K073140 · DSI
Mennen Medical , Ltd.
Cardiovascular · 14d
Cleared Nov 21, 2007
PADNET+
K073146 · JOM
Biomedix, Inc.
Cardiovascular · 13d
Cleared Nov 21, 2007
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL
K073181 · MOS
Neocoil, LLC
Radiology · 8d
Cleared Nov 20, 2007
IMPLANTIUM PROSTHETICS
K070228 · NHA
Dentium Co., Ltd.
Dental · 300d
Cleared Nov 20, 2007
BBL CHROMAGAR 0157
K070691 · JSI
Becton, Dickinson & CO
Microbiology · 252d
Cleared Nov 20, 2007
PEF TUBE
K071579 · KNT
N.M. Beale Co., Inc.
Gastroenterology & Urology · 165d
Cleared Nov 20, 2007
CELLSEARCH CIRCULATING TUMOR CELL KIT
K071729 · NQI
Veridex, LLC
Pathology · 148d
Cleared Nov 20, 2007
SYSMEX XE-5000
K071967 · GKZ
Sysmex America, Inc.
Hematology · 127d
Cleared Nov 20, 2007
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
K072133 · NDN
Cardinal Health, Inc.
Orthopedic · 110d