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
39841–39864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2013
VIDA LED SURGICAL LIGHTING SYSTEM
K132307 · FSY
Convida Healthcare & Systems Corporation
General & Plastic Surgery · 104d
Cleared Nov 05, 2013
NURO NEUROMODULATION SYSTEM
K132561 · NAM
Advanced Uro-Solutions, Inc.
Gastroenterology & Urology · 82d
Cleared Nov 05, 2013
ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE...
K132567 · LJS
Covidien
General Hospital · 82d
Cleared Nov 04, 2013
MECTACER BIOLOX OPTION HEADS
K131518 · LZO
Medacta International
Orthopedic · 160d
Cleared Nov 04, 2013
ARIX HAND SYSTEM
K131566 · HRS
Jeil Medical Corporation
Orthopedic · 158d
Cleared Nov 04, 2013
LIGHTHOUSE(TM) URINARY CATHETER
K131655 · EZL
Seedings Life Science Ventures, LLC
Gastroenterology & Urology · 151d
Cleared Nov 04, 2013
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE,...
K131700 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 146d
Cleared Nov 04, 2013
WOLF LONG BONE PLATE SYSTEM
K131834 · HRS
Toby Orthopaedics
Orthopedic · 137d
Cleared Nov 04, 2013
X-PORTE ULTRASOUND SYSTEM
K133134 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d
Cleared Nov 01, 2013
CLEARPATH ALIGNER
K123514 · NXC
Qserve America, Inc.
Dental · 352d
Cleared Nov 01, 2013
SCANNING LASERLINK
K130195 · HQF
Lumenis, Inc.
Ophthalmic · 277d
Cleared Nov 01, 2013
SILK ROAD ACCESS CATHETER
K130649 · DQY
Silk Road Medical, Inc.
Cardiovascular · 235d
Cleared Nov 01, 2013
AMBU ASCOPE 3 5.0/2.2
K130845 · EOQ
Ambu A/S
Ear, Nose, Throat · 220d
Cleared Nov 01, 2013
PETITE BASIC SYSTEM 701 ELT
K131420 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 169d
Cleared Nov 01, 2013
PERIMETER INTERBODY FUSION DEVICE
K131669 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 147d
Cleared Nov 01, 2013
RAYSCAN A-EXPERT
K131693 · MUH
Ray Co., Ltd.
Radiology · 144d
Cleared Nov 01, 2013
RAYSCAN A-EXPERT 3D
K131695 · OAS
Ray Co., Ltd.
Radiology · 144d
Cleared Nov 01, 2013
ENAMELAST
K132109 · LBH
Ultradent Products Inc. / Oratech, LLC
Dental · 116d
Cleared Nov 01, 2013
KLARITY VACUUM BAG, KLARITY MOLD CUSHION
K132124 · IYE
Klarity Medical Products, LLC
Radiology · 114d
Cleared Nov 01, 2013
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL...
K132450 · KLE
Kuraray Noritake Dental, Inc.
Dental · 87d
Cleared Nov 01, 2013
QUIET/SILENT SCANNING SUITE
K132831 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared Nov 01, 2013
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
K132883 · HRX
Hemodia Sas
Orthopedic · 49d
Cleared Oct 31, 2013
INVOTEC LARYNGEAL ELECTRODE
K122040 · ETN
Invotec International, Inc.
Ear, Nose, Throat · 476d
Cleared Oct 31, 2013
LUNA DENTAL IMPLANT SYSTEM
K123155 · DZE
Shinhung Mst Co., Ltd.
Dental · 387d