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
30793–30816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2016
FortiBridge Anterior Cervical Plate System
K162250 · KWQ
Nanovis Spine, LLC
Orthopedic · 77d
Cleared Oct 26, 2016
CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN...
K162469 · GEI
Medos International SARL
General & Plastic Surgery · 54d
Cleared Oct 26, 2016
Multichem A1c
K162514 · JJX
Technopath Manufacturing
Chemistry · 48d
Cleared Oct 26, 2016
NeuroBlate System
K162762 · GEX
Monteris Medical, Inc.
General & Plastic Surgery · 26d
Cleared Oct 25, 2016
Tempo Temporary Pacing Lead
K160260 · LDF
Biotrace Medical, Inc.
Cardiovascular · 267d
Cleared Oct 25, 2016
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond...
K161042 · KLE
Kuraray Noritake Dental, Inc.
Dental · 195d
Cleared Oct 25, 2016
G-scan Brio, S-scan
K161973 · LNH
Esaote, S.P.A.
Radiology · 99d
Cleared Oct 25, 2016
chromID MRSA
K162076 · JSO
bioMerieux, Inc.
Microbiology · 90d
Cleared Oct 25, 2016
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device...
K162080 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 90d
Cleared Oct 25, 2016
NIRO-200NX DP
K162117 · MUD
Hamamatsu Photonics K.K.
Cardiovascular · 88d
Cleared Oct 25, 2016
vRad PACS with Mammography
K162145 · LLZ
Virtual Radiologic Corporation
Radiology · 85d
Cleared Oct 25, 2016
Solana Strep Complete Assay
K162274 · PGX
Quidel Corporation
Microbiology · 74d
Cleared Oct 25, 2016
syngo.via RT Image Suite
K162370 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 62d
Cleared Oct 25, 2016
KATOR Suture Anchor
K162386 · MBI
Kator, LLC
Orthopedic · 61d
Cleared Oct 25, 2016
PowerPICC Provena Catheters
K162443 · LJS
C.R. Bard, Inc.
General Hospital · 55d
Cleared Oct 25, 2016
truFreeze System
K162695 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 28d
Cleared Oct 25, 2016
Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT
K162736 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Oct 24, 2016
Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano...
K151399 · EBF
Schutz-Dental GmbH
Dental · 517d
Cleared Oct 24, 2016
Caremed patient cable and leadwires
K153188 · DSA
Shenzhen Caremed Medical Technology...
Cardiovascular · 356d
Cleared Oct 24, 2016
Visco (olifilcon A) soft contact lens
K160245 · LPL
Visco Vision, Inc.
Ophthalmic · 266d
Cleared Oct 24, 2016
NeoSpan Compression Staple Impant w/instruments
K161426 · JDR
In2bones USA, LLC
Orthopedic · 154d
Cleared Oct 24, 2016
Acclarent NavWire Sinus Navigation Guidewire
K161697 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 126d
Cleared Oct 24, 2016
Relieva UltirraNav Sinus Balloon Catheter
K161698 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 126d
Cleared Oct 24, 2016
CARTO ENT System
K161701 · PGW
Biosense Webster
Ear, Nose, Throat · 126d