FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
21745–21768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2019
ADI Cervical Interbody Fusion Device
K191812 · ODP
Additive Device, Inc. (Adi) D/B/A...
Orthopedic · 111d
Cleared Oct 24, 2019
MU2net
K191944 · IYE
Dosisoft
Radiology · 94d
Cleared Oct 24, 2019
Genesys Spine Binary® Lumbar Plate System
K192678 · KWQ
Genesys Spine
Orthopedic · 28d
Cleared Oct 24, 2019
Revolution Maxima, Revolution Ace
K192686 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 28d
Cleared Oct 24, 2019
Upgrade Kit MR GUI PRO, MrJ 3300 Plus
K192690 · LNH
Asg Superconductors S.P.A.
Radiology · 28d
Cleared Oct 24, 2019
Padlock Clip defect closure system, Padlock Pro-Select defect closure device
K192722 · PKL
STERIS Corporation
Gastroenterology & Urology · 27d
Cleared Oct 24, 2019
Agnes
K192728 · GEI
Agnes Medical Co., Ltd.
General & Plastic Surgery · 27d
Cleared Oct 23, 2019
Patient-Specific Airway Stent
K182743 · NWA
New Cos, Inc.
Anesthesiology · 390d
Cleared Oct 23, 2019
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black...
K183562 · LZC
Encompass Industries Sdn. Bhd.
General Hospital · 307d
Cleared Oct 23, 2019
Diana ChemoClave Transfer Set
K190157 · ONB
Icu Medical
General Hospital · 266d
Cleared Oct 23, 2019
Intraosseous infusion device
K191258 · FMI
Einstein Works, LLC
General Hospital · 166d
Cleared Oct 23, 2019
Alliance Glenoid
K191814 · KWS
Zimmer, Inc.
Orthopedic · 110d
Cleared Oct 23, 2019
RESONATE Anterior Cervical Plate System
K192314 · KWQ
Globus Medical, Inc.
Orthopedic · 58d
Cleared Oct 22, 2019
stentfix OTSC System Set
K183309 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 327d
Cleared Oct 22, 2019
ClearEdge Balance System
K183661 · LXV
Quadrant Biosciences
Ear, Nose, Throat · 299d
Cleared Oct 22, 2019
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile,...
K190539 · FMG
Monumedical, LLC
General Hospital · 232d
Cleared Oct 22, 2019
Exactech Alteon Modular Dual Mobility (MDM) System
K190890 · LZO
Exactech, Inc.
Orthopedic · 200d
Cleared Oct 22, 2019
Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
K191073 · NUJ
Vein 360, LLC
General & Plastic Surgery · 183d
Cleared Oct 22, 2019
VICRYL Mesh
K191373 · FTL
Ethicon, Inc.
General & Plastic Surgery · 152d
Cleared Oct 22, 2019
FORTICO Anterior Cervical Fixation System
K191584 · KWQ
Camber Spine Technologies, LLC
Orthopedic · 130d
Cleared Oct 22, 2019
Lumpipulse G CA19-9-N
K191973 · NIG
Fujirebio Dianostics, Inc.
Immunology · 90d
Cleared Oct 22, 2019
DORO QR3 XTom Headholder System
K191979 · HBL
Pro-Med Instruments GmbH
Neurology · 90d
Cleared Oct 22, 2019
Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle...
K192001 · FRC
Sterilucent, Inc.
General Hospital · 88d
Cleared Oct 22, 2019
Madison Total Knee System
K192084 · JWH
Implanet, S.A.
Orthopedic · 81d