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
34273–34296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · NUH
Andon Health Co, Ltd.
Neurology · 217d
Cleared Aug 14, 2015
Sertera Biopsy Device
K150169 · KNW
Hologic, Inc.
Gastroenterology & Urology · 200d
Cleared Aug 14, 2015
IDODENTINE DISC, IDODENTINE BLOCK
K150432 · EBG
Union Dental S.A.
Dental · 176d
Cleared Aug 14, 2015
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
K150728 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 147d
Cleared Aug 14, 2015
Vyntus / SentrySuite Product Line
K150810 · BZC
Carefusion Germany 234 GmbH
Anesthesiology · 141d
Cleared Aug 14, 2015
Banana Gold
K150857 · HIS
Hankook Latex Gongup Co., Ltd.
Obstetrics & Gynecology · 136d
Cleared Aug 14, 2015
MASTERGRAFT Contain
K151172 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 105d
Cleared Aug 14, 2015
Wartie Advanced Wart Remover or other proprietary name
K151309 · GEH
Youmedical Corp BV
General & Plastic Surgery · 88d
Cleared Aug 14, 2015
Low Dose CT Lung Cancer Screening Option for Qualified GE Systems
K151372 · JAK
Ge Medical Systems, LLC
Radiology · 85d
Cleared Aug 14, 2015
Flexor Radial Hydrophilic Introducer Access Set
K152044 · DYB
Cook Incorporated
Cardiovascular · 22d
Cleared Aug 13, 2015
Mitsar-EEG
K143233 · GWQ
Mitsar Co., Ltd.
Neurology · 276d
Cleared Aug 13, 2015
Accu-Chek FlexLink Plus infusion set
K143446 · FPA
Roche Diagnostics GmbH
General Hospital · 254d
Cleared Aug 13, 2015
Neurosplint
K143458 · IQI
Neurospectrum, LLC
Physical Medicine · 252d
Cleared Aug 13, 2015
Narval Brux
K143623 · MQC
Resmed Sas
Dental · 234d
Cleared Aug 13, 2015
ComboCath OTW PTA Dilatation Catheter
K150452 · LIT
Summa Therapeutics, LLC
Cardiovascular · 174d
Cleared Aug 13, 2015
Stryker Suture Tape
K150584 · GAT
Stryker
General & Plastic Surgery · 157d
Cleared Aug 13, 2015
Modpod
K150695 · ITH
Hollywog, LLC
Physical Medicine · 148d
Cleared Aug 13, 2015
CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)
K150703 · KLE
Kuraray Noritake Dental, Inc.
Dental · 148d
Cleared Aug 13, 2015
Foundation Interbody Devices
K150847 · ODP
Corelink, LLC
Orthopedic · 135d
Cleared Aug 13, 2015
Aesculap T-Space PEEK and XP Spinal System
K151056 · MAX
Aesculap Implant Systems, LLC
Orthopedic · 115d
Cleared Aug 13, 2015
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID
K151142 · EBI
Wieland Dental + Technik GmbH & Co. KG
Dental · 106d
Cleared Aug 13, 2015
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral...
K151200 · GAM
Ethicon, Inc.
General & Plastic Surgery · 100d
Cleared Aug 13, 2015
Airlock® osteosynthesis plate system
K151277 · HRS
Novastep
Orthopedic · 91d
Cleared Aug 13, 2015
U2 Hip Stem, Ti Porous Coated, Matrix
K151316 · LPH
United Orthopedic Corporation
Orthopedic · 87d