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
32425–32448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K143690 · PHL
Ekso Bionics, Inc.
Neurology · 464d
Cleared Apr 01, 2016
Fiagon Navigation System
K151156 · HAW
Fiagon GmbH
Neurology · 336d
Cleared Apr 01, 2016
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
K152881 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 184d
Cleared Apr 01, 2016
Pulpdent Solo Flowable Composite with MCP
K153249 · EBF
Pulpdent Corporation
Dental · 144d
Cleared Apr 01, 2016
Aquilion Lightning, TSX-035A/4 and /5, V7.0
K153263 · JAK
Toshibamedical Systems Corporation
Radiology · 143d
Cleared Apr 01, 2016
Affirm Prone Biopsy System
K153486 · IZH
Hologic, Inc.
Radiology · 119d
Cleared Apr 01, 2016
Powder Free Blue Nitrile Examination Glove
K153562 · LZA
Vietglove Corporation
General Hospital · 109d
Cleared Apr 01, 2016
BioVision Plus
K153583 · MWP
Faxitron Bioptics, LLC
Radiology · 108d
Cleared Apr 01, 2016
X5 Digital Color Doppler Ultrasound System
K160258 · IYN
Sonoscape Medical Corp.
Radiology · 60d
Cleared Apr 01, 2016
PlasmaFlow
K160318 · JOW
Manamed, Inc.
Cardiovascular · 56d
Cleared Apr 01, 2016
Premier
K160320 · MNI
Shandong Weigao Orthopaedic Device...
Orthopedic · 56d
Cleared Apr 01, 2016
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
K160459 · PCH
Biofire Diagnostics, LLC
Microbiology · 42d
Cleared Mar 31, 2016
NewTom VGi evo
K151612 · OAS
Qr S.R.L.
Radiology · 290d
Cleared Mar 31, 2016
NOVATECH TALCAIR
K151832 · GCJ
Novatech SA
General & Plastic Surgery · 269d
Cleared Mar 31, 2016
Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing
K151932 · HRX
Stryker Corporation
Orthopedic · 261d
Cleared Mar 31, 2016
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy...
K151997 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 255d
Cleared Mar 31, 2016
Pure Tilt
K152021 · IOR
Proactive Comfort, LLC
Physical Medicine · 254d
Cleared Mar 31, 2016
T3 Software
K152258 · PLB
Etiometry, Inc.
Cardiovascular · 233d
Cleared Mar 31, 2016
SensiCare PI Surgical Gloves
K152428 · KGO
Medline Industries, Inc.
General Hospital · 218d
Cleared Mar 31, 2016
Revitive Medic
K152480 · NGX
Actegy , Ltd.
Physical Medicine · 213d
Cleared Mar 31, 2016
ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY
K152969 · KCT
Conmed Corporation
General Hospital · 175d
Cleared Mar 31, 2016
Infrared Ear Thermometer
K153146 · FLL
Sejoy Electronics & Instruments Co.,...
General Hospital · 153d
Cleared Mar 31, 2016
SICAT OPTISLEEP
K153291 · LRK
Sicat GmbH & Co. KG
Dental · 139d
Cleared Mar 31, 2016
JAZZ LOCK
K153348 · OWI
Implanet, S.A.
Orthopedic · 132d