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
41881–41904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2013
MULTIPLE NAME
K123819 · LYY
Top Calibre Sdn Bhd
General Hospital · 83d
Cleared Mar 05, 2013
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
K123837 · MTD
Biosense Webster, Inc.
Cardiovascular · 82d
Cleared Mar 05, 2013
RESTORELLE Y CONTOUR
K123914 · OTO
Coloplast A/S
Obstetrics & Gynecology · 76d
Cleared Mar 05, 2013
SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
K123980 · NRB
Misonix, Inc.
General & Plastic Surgery · 69d
Cleared Mar 05, 2013
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K123993 · OVD
Alphatec Spine, Inc.
Orthopedic · 69d
Cleared Mar 05, 2013
SUPERIOR LATERAL VARIAX CLAVICLE PLATE
K130116 · HRS
Stryker Trauma AG
Orthopedic · 48d
Cleared Mar 04, 2013
INBONE ( I AND II) TOTAL ANKLE SYSTEMS
K123059 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 154d
Cleared Mar 04, 2013
DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION...
K123188 · JCX
Dornoch Medical Systems, Inc.
General & Plastic Surgery · 144d
Cleared Mar 04, 2013
AVENIR MULLER STEM
K123392 · LZO
Zimmer GmbH
Orthopedic · 122d
Cleared Mar 04, 2013
UCENTUM
K123717 · NKB
Ulrich GmbH & Co. KG
Orthopedic · 90d
Cleared Mar 04, 2013
URSA ANGIOGRAPHIC CATHETER
K123818 · DQO
Curative Medical Technology, Inc.
Cardiovascular · 82d
Cleared Mar 04, 2013
ACLEARA, THERACLEAR
K123889 · ONF
Theravant Corporation
General & Plastic Surgery · 76d
Cleared Mar 04, 2013
CURA COLLIMATOR
K123893 · IXI
Cura Medical Technologies, LLC
Radiology · 76d
Cleared Mar 04, 2013
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE...
K130307 · KRD
Celonova Biosciences, Inc.
Cardiovascular · 25d
Cleared Mar 01, 2013
UNIGOLD GIARDIA
K120001 · MHI
Trinity Biotech
Microbiology · 423d
Cleared Mar 01, 2013
EVOLUTION BILIARY STENT SYSTEM
K121430 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 291d
Cleared Mar 01, 2013
REXTAR, REXTAR LCD
K122016 · EHD
Meta Biomed, Inc.
Radiology · 234d
Cleared Mar 01, 2013
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
K122590 · DQX
Terumo Medical Corporation
Cardiovascular · 189d
Cleared Mar 01, 2013
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
K122955 · ELM
Wright Health Group , Ltd.
Dental · 157d
Cleared Mar 01, 2013
VERTEX THERMOSENS RIGID
K123220 · EBI
Vertex-Dental B.V.
Dental · 137d
Cleared Mar 01, 2013
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
K123365 · HET
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 121d
Cleared Mar 01, 2013
MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS
K123426 · LLZ
Orpheus Medical , Ltd.
Radiology · 114d
Cleared Mar 01, 2013
TM ARDIS INTERBODY SYSTEM INSERTER
K123602 · MAX
Zimmer Trabecular Metal Technology
Orthopedic · 100d
Cleared Mar 01, 2013
CASSI II ROTATIONAL CORE BIOPSY SYSTEM
K123606 · KNW
Scion Medical Technologies, LLC
Gastroenterology & Urology · 100d