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
44689–44712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2012
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
K120252 · GWM
Raumedic AG
Neurology · 75d
Cleared Apr 11, 2012
KONAN SPECULAR MICROSCOPE XIV
K120264 · NQE
Konan Medical, Inc.
Ophthalmic · 72d
Cleared CT Apr 10, 2012
FINESSE PERSONAL INSULIN DELIVERY PATCH
K111924 · OPP
Calibra Medical, Inc.
General Hospital · 279d
Cleared Apr 10, 2012
STERILE LUBRICATING JELLY
K112110 · KMJ
Jianerkang Medical Dressing Company
General Hospital · 263d
Cleared Apr 10, 2012
AQUILION CXL
K112989 · JAK
Toshiba America Medical Systems, In.C
Radiology · 187d
Cleared Apr 10, 2012
AQUILION ONE
K113466 · JAK
Toshiba Medical Systems Coporation,...
Radiology · 140d
Cleared Apr 10, 2012
PEDCAT
K113548 · JAK
Curvebeam, LLC
Radiology · 131d
Cleared Apr 10, 2012
DEFLEX
K113608 · EBI
Nuxen S.R.L.
Dental · 126d
Cleared Apr 10, 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
K120157 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 83d
Cleared Apr 10, 2012
SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
K120390 · HWC
Solana Surgical, LLC
Orthopedic · 63d
Cleared Apr 10, 2012
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE...
K120774 · DSI
Welch Allyn, Inc.
Cardiovascular · 27d
Cleared Apr 09, 2012
WEIGHT AND BODY FAT SCALE SHINE BS0105
K112149 · MNW
Shine Overseas Marketing Limited
Gastroenterology & Urology · 258d
Cleared Apr 09, 2012
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
K112481 · KXE
Ascension Orthopedic
Orthopedic · 224d
Cleared Apr 09, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
K112653 · JJX
ACON Laboratories, Inc.
Chemistry · 210d
Cleared Apr 09, 2012
SONIXGPS VASCULAR ACCESS NEEDLE KIT
K120349 · DRE
Ultrasonix Medical Corpation
Cardiovascular · 63d
Cleared Apr 09, 2012
CAPSTONE CONTROL SPINAL SYSTEM
K120368 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Apr 09, 2012
PIXEL APP
K120473 · LWH
Gauss Surgical, Inc.,
General & Plastic Surgery · 53d
Cleared Apr 09, 2012
AEROSYNC FOR AERODR SYSTEM
K120477 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 53d
Cleared Apr 06, 2012
IMAGE1 GI CCU MODEL 22203020-114
K111997 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 268d
Cleared Apr 06, 2012
ETHEREA
K112505 · GEX
Regulatory Insight, Inc.
General & Plastic Surgery · 220d
Cleared Apr 06, 2012
ARTHREX BIO-SUTURE
K112899 · GAT
Arthrex, Inc.
General & Plastic Surgery · 186d
Cleared Apr 06, 2012
CERVICAL PLATE
K113170 · KWQ
Eisertech, LLC
Orthopedic · 162d
Cleared Apr 06, 2012
POWER WHEELCHAIR
K113463 · ITI
Suzhou KD Medical Appliance Co., Ltd.
Physical Medicine · 136d
Cleared Apr 06, 2012
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE...
K120095 · GEI
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 85d