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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
64585–64608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2005
LONGFEI LFY-I-5 OXYGEN CONCENTRATOR
K033405 · CAW
Zhejiang Longfei Industrial Co., Ltd.
Anesthesiology · 725d
Cleared Oct 18, 2005
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
K051888 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 98d
Cleared Oct 18, 2005
QUICKSMILE
K052040 · EEG
Cosmetic Dental Materials, Inc.
Dental · 82d
Cleared Oct 18, 2005
PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
K052433 · MWP
Bioptics, Inc.
Radiology · 42d
Cleared Oct 17, 2005
NEWGEL AND NEWGEL PLUS E
K041704 · MDA
Newmedical Technology, Inc.
General & Plastic Surgery · 481d
Cleared Oct 17, 2005
BIODERM SCIENCES WOUND CREAM
K042352 · FRO
Bioderm Sciences, Inc.
General & Plastic Surgery · 413d
Cleared Oct 17, 2005
TECTONIC CERVICAL PLATE SYSTEM
K051531 · KWQ
K2m, LLC
Orthopedic · 130d
Cleared Oct 17, 2005
ELECSYS PRECICONTROL BONE
K051543 · JJY
Roche Diagnostics Corp.
Chemistry · 129d
Cleared Oct 17, 2005
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
K051815 · KWQ
Vertebron, Inc.
Orthopedic · 104d
Cleared Oct 17, 2005
PROVEN REVISION MODULAR TIBIAL TRAY
K051976 · JWH
Stelkast Company
Orthopedic · 88d
Cleared Oct 17, 2005
URGENT PC NEUROMODULATION SYSTEM
K052025 · NAM
Uroplasty, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 17, 2005
3.8MM CS FACET COMPRESSION DEVICE
K052043 · MRW
Triage Medical, Inc.
Orthopedic · 81d
Cleared Oct 17, 2005
ACTICLOT, MODEL 824
K052124 · GJS
American Diagnostica, Inc.
Hematology · 73d
Cleared Oct 17, 2005
I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
K052175 · OTN
Uroplasty, Inc.
Gastroenterology & Urology · 68d
Cleared Oct 17, 2005
REVENEER CERAMIC REPAIR SYSTEM
K052189 · KLE
Schutz-Dental GmbH
Dental · 67d
Cleared Oct 17, 2005
REFORMAT GATEWAY
K052284 · LLZ
Infinitt Co., Ltd.
Radiology · 56d
Cleared Oct 17, 2005
HDR IORT SHIELDED APPLICATOR
K052351 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 49d
Cleared Oct 17, 2005
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
K052365 · HEE
Rocket Medical Plc
Obstetrics & Gynecology · 49d
Cleared Oct 17, 2005
OLECRANONPLATE WITH ANGULAR STABILITY
K052368 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 49d
Cleared Oct 17, 2005
ICY CATHETER, MODEL IC-3893A
K052443 · NCX
Alsius Corp.
Neurology · 41d
Cleared Oct 17, 2005
CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163,...
K052449 · GEI
Codman & Shurtleff, Inc.
General & Plastic Surgery · 41d
Cleared Oct 17, 2005
ARTELON SURGICAL SUTURE
K052482 · GAR
Artimplant AB
General & Plastic Surgery · 38d
Cleared Oct 17, 2005
FRAGMENT SPECIFIC FIXATOR
K052498 · KTT
David J. Slutsky MD
Orthopedic · 35d
Cleared Oct 17, 2005
DAR-8000F
K052500 · IZI
Shimadzu Medical Systems
Radiology · 34d