FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
36817–36840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2014
WALKAIDE SYSTEM
K140886 · GZI
Innovative Neurotronics, Inc.
Neurology · 123d
Cleared Aug 08, 2014
HYDROCLEANSE WOUND CARE SOLUTION
K141012 · FRO
Oculus Innovative Sciences
General & Plastic Surgery · 109d
Cleared Aug 08, 2014
LITHO
K141101 · GEX
Quanta System Spa
General & Plastic Surgery · 101d
Cleared Aug 07, 2014
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
K131384 · KMF
Kericure, Inc.
General & Plastic Surgery · 450d
Cleared Aug 07, 2014
TON-95LH, PAX-I3D ORTHO
K132983 · OAS
VATECH Co., Ltd.
Radiology · 318d
Cleared Aug 07, 2014
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K133168 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 294d
Cleared Aug 07, 2014
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO...
K133538 · NWB
Olympus Corporation of the Americas
Gastroenterology & Urology · 262d
Cleared Aug 07, 2014
TITAN 11
K133695 · KPR
Gemss Medical Systems Co., Ltd.
Radiology · 247d
Cleared Aug 07, 2014
PREMVIA
K134037 · KGN
Biotime, Inc.
General & Plastic Surgery · 219d
Cleared Aug 07, 2014
LATERAL VBR SYSTEM
K140563 · MQP
Nu Vasive, Incorporated
Orthopedic · 155d
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