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
41353–41376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2013
SLEEK OTW PTA CATHETER
K130786 · LIT
C.R. Bard, Inc.
Cardiovascular · 43d
Cleared May 02, 2013
GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
K120532 · PEC
Getinge Sourcing, LLC
General Hospital · 435d
Cleared May 02, 2013
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
K122196 · GWQ
Blackrock Neuromed, LLC
Neurology · 282d
Cleared May 02, 2013
WATERLASE IPLUS ALL TISSUE LASER
K122368 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 269d
Cleared May 02, 2013
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
K122388 · MNW
Seca GmbH & Co. KG
Gastroenterology & Urology · 269d
Cleared May 02, 2013
SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE...
K122525 · NBW
Biotest Medical Corp.
Chemistry · 255d
Cleared May 02, 2013
AQUILION LB TRITON V4.91
K123500 · JAK
Toshibamedical Systems Corporation
Radiology · 170d
Cleared May 02, 2013
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN...
K123953 · KHS
Alfa Wassermann Diagnostic...
Chemistry · 132d
Cleared May 02, 2013
CYNOSURE 1064NM DIODE LASER
K123971 · ILY
Cynosure, Inc.
Physical Medicine · 127d
Cleared May 02, 2013
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
K130039 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 115d
Cleared May 02, 2013
DVTCARE CA5
K130174 · JOW
Ossur Americas, Inc.
Cardiovascular · 98d
Cleared May 02, 2013
RANGE SPINAL SYSTEM
K130330 · OSH
K2m, Inc.
Orthopedic · 80d
Cleared May 02, 2013
SYNERGY FOCUS DESKTOP VERSION
K130346 · GWF
Natus Neurology Incorporated
Neurology · 80d
Cleared May 02, 2013
SUPERA VERITAS
K130591 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 56d
Cleared May 02, 2013
INOMAX DSIR (DELIVERY SYSTEM)
K130605 · MRN
Ino Therapeutics
Anesthesiology · 56d
Cleared May 02, 2013
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
K130811 · DKZ
Psychemedics Corp.
Toxicology · 38d
Cleared May 02, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
K130870 · CIC
Hitachi Chemical Diagnostics, Inc.
Chemistry · 34d
Cleared May 01, 2013
TENDER TOUCH
K121401 · ILY
Sometech Corporation
Physical Medicine · 356d
Cleared May 01, 2013
AGILIA INFUSION SYSTEM
K121613 · FRN
Fresenius Kabi AG
General Hospital · 334d
Cleared May 01, 2013
ELISIO-H AND ELISIO-M HEMODIALYZERS
K122347 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 271d
Cleared May 01, 2013
HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN...
K122595 · FRO
Dermal Life, LLC
General & Plastic Surgery · 250d
Cleared May 01, 2013
UTF STEM, REDUCED
K123550 · LPH
United Orthopedic Corporation
Orthopedic · 163d
Cleared May 01, 2013
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT...
K123636 · GZI
Bioness, Inc.
Neurology · 159d
Cleared May 01, 2013
ZYGAFIX SPINAL FACET SCREW SYSTEM
K123932 · MRW
X-Spine Systems, Inc.
Orthopedic · 132d