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
53569–53592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2009
AUTOSUTURE PROTACK
K090470 · OCW
Covidien
General & Plastic Surgery · 80d
Cleared May 14, 2009
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
K090489 · FTL
Kci USA, Inc.
General & Plastic Surgery · 78d
Cleared May 14, 2009
WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING...
K091073 · KPS
Ultraspect , Ltd.
Radiology · 30d
Cleared May 13, 2009
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
K081803 · DRF
St Jude Medical
Cardiovascular · 321d
Cleared May 13, 2009
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1
K091040 · FLL
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared May 13, 2009
ELITE MPX LASER SYSTEM WITH CRYO C
K091169 · GEX
Cynosure, Inc.
General & Plastic Surgery · 21d
Cleared May 12, 2009
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS...
K083214 · DQY
Aga Medical Corp.
Cardiovascular · 193d
Cleared May 12, 2009
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
K083838 · MNW
Fook Tin Technologies Limited
Gastroenterology & Urology · 140d
Cleared May 12, 2009
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
K090187 · NBW
Taidoc Technology Corporation
Chemistry · 106d
Cleared May 12, 2009
LAMINOPLASTY PLATING SYSTEM
K090354 · NQW
Aesculap Implant System, Inc.
Orthopedic · 90d
Cleared May 12, 2009
SEGMENT
K090833 · LLZ
Medviso
Radiology · 47d
Cleared May 12, 2009
CRONO S-PID 50
K091042 · FRN
Cane S.R.L.
General Hospital · 29d
Cleared May 12, 2009
NMI PICC
K091261 · LJS
Navilyst Medical, Inc.
General Hospital · 13d
Cleared May 11, 2009
MULTI-CHANNEL LASER THERAPY SYSTEM
K082686 · ILY
United Integrated Services Co., Ltd.
Physical Medicine · 238d
Cleared May 11, 2009
REFINE LIFT SYSTEM
K083102 · FTL
Alure Medical, Inc.
General & Plastic Surgery · 203d
Cleared May 11, 2009
SOCKIT! AND MCMERLIN DERMAL WOUND GEL
K090092 · FRO
Mcmerlin Dental Products LP
General & Plastic Surgery · 117d
Cleared May 11, 2009
PULPDENT MICRO-HYBRID COMPOSITE
K090391 · EBF
Pulpdent Corporation
Dental · 83d
Cleared May 11, 2009
FSC 2
K090601 · NTN
Schoelly Imaging, Inc.
Gastroenterology & Urology · 67d
Cleared May 11, 2009
MONOBOND PLUS
K090826 · KLE
Ivoclar Vivadent, Inc.
Dental · 46d
Cleared May 11, 2009
POWER DRIVE CHAIR, MODEL: TMM6
K091043 · INK
Transmotion Medical, Inc.
Physical Medicine · 28d
Cleared May 11, 2009
MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER,...
K091113 · INI
Pride Mobility Products Corp.
Physical Medicine · 24d
Cleared May 08, 2009
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1,...
K081286 · MYA
Dako North America, Inc.
Pathology · 366d
Cleared May 08, 2009
CRANIAL IMAGE GUIDED SURGERY SYSTEM
K082060 · HAW
Brainlab AG
Neurology · 291d
Cleared May 08, 2009
PMT SUBDURAL CORTICAL ELECTRODES
K082474 · GYC
Pmt Corp.
Neurology · 253d