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
37417–37440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2014
SPORVIEW PLUS BI TEST PACK
K140620 · FRC
Crosstex International
General Hospital · 149d
Cleared Aug 07, 2014
MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
K140812 · FSY
Medical Illumination International, Inc.
General & Plastic Surgery · 128d
Cleared Aug 07, 2014
LCD MONITOR
K140956 · LNH
Nordicneurolab
Radiology · 115d
Cleared Aug 07, 2014
Z-LINK CERVICAL
K141005 · OVE
Zavation, LLC
Orthopedic · 111d
Cleared Aug 07, 2014
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED)...
K141209 · KRD
Celonova Biosciences, Inc.
Cardiovascular · 90d
Cleared Aug 07, 2014
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION...
K141236 · LOX
Boston Scientific Corporation
Cardiovascular · 86d
Cleared Aug 07, 2014
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
K141241 · HRS
Synthes USA Products, LLC
Orthopedic · 86d
Cleared Aug 07, 2014
ECLIPSE TREATMENT PLANNING SYSTEM
K141283 · MUJ
Varian Medical Systems, Inc.
Radiology · 83d
Cleared Aug 07, 2014
OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
K141365 · MQE
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 76d
Cleared Aug 07, 2014
SONICISION CORDLESS ULTRASONIC DISSECTOR
K141371 · LFL
Covidien, Formerly Valleylab, A...
General & Plastic Surgery · 72d
Cleared Aug 07, 2014
LITHO DK30
K141403 · GEX
Quanta System Spa
General & Plastic Surgery · 71d
Cleared Aug 07, 2014
NASOPORE-FD
K141423 · LYA
Polyganics B.V.,
Ear, Nose, Throat · 69d
Cleared Aug 07, 2014
KIMGUARD ONE-STEP STERILIZATION WRAP
K141612 · FRG
Kimberly-Clark Health Care
General Hospital · 52d
Cleared Aug 07, 2014
MAGELLAN ROBOTIC SYSTEM
K141614 · DXX
Hansen Medical
Cardiovascular · 52d
Cleared Aug 07, 2014
HI-TORQUE VERSATURN GUIDE WIRE
K141782 · DQX
Abbott Vascular
Cardiovascular · 36d
Cleared Aug 07, 2014
SAGITTILT
K141787 · IYE
Orfit Industries NV
Radiology · 36d
Cleared Aug 07, 2014
AAP LOQTEC CLAVICLE PLATES 2.7/3.5
K141823 · HRS
Aap Implantate AG
Orthopedic · 31d
Cleared Aug 07, 2014
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
K141846 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 07, 2014
BREAST VOLUME NAVIGATOR
K141870 · IYN
Metritrack, LLC
Radiology · 27d
Cleared Aug 07, 2014
Straumann Bone Level NC Angled Screw Retained Abutments
K141871 · NHA
Straumann USA, LLC
Dental · 27d
Cleared Aug 07, 2014
PATHASSIST LED LIGHT FIBER
K141916 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Aug 07, 2014
VARIAX 2 SYSTEM
K141992 · HRS
Stryker Trauma AG
Orthopedic · 16d
Cleared Aug 06, 2014
IQ TECHNOLOGIES
K131290 · NUH
Iq Technologies, Inc.
Neurology · 457d
Cleared Aug 06, 2014
SAAD PATIENT MONITOR (SPM)
K133222 · MHX
Hanin Medical Services Co., Ltd.
Cardiovascular · 292d