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
33745–33768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2015
Bard Snare Retrieval Kit
K152560 · MMX
Neometrics, Inc.
Cardiovascular · 44d
Cleared Oct 23, 2015
geko T-2 Neuromuscular Stimulator
K152677 · IPF
Firstkind Limited
Physical Medicine · 35d
Cleared Oct 23, 2015
illumigene Mycoplasma DNA Amplification Assay
K152800 · OZX
Meridian Bioscience, Inc.
Microbiology · 25d
Cleared Oct 22, 2015
Masimo MightySat Rx Fingertip Pulse Oximeter
K150314 · DQA
Masimo Corporation
Anesthesiology · 255d
Cleared Oct 22, 2015
TSolution One w/ACG surgical System
K150741 · OJP
THINK Surgical, Inc.
Orthopedic · 213d
Cleared Oct 22, 2015
330psi Extension Y-Line with Dual Check Valve
K150902 · DXT
Coeur, Inc.
Cardiovascular · 202d
Cleared Oct 22, 2015
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
K151386 · FTL
Atrium Medical Corporation
General & Plastic Surgery · 149d
Cleared Oct 22, 2015
Carbamazepine Gen 4
K151578 · KLT
Roche Diagnostics Operations (Rdo)
Toxicology · 133d
Cleared Oct 22, 2015
P.R.O. CG Manual Wheelchair
K151893 · IOR
Freedom Designs, Inc.
Physical Medicine · 104d
Cleared Oct 22, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151895 · FCG
Boston Scientific Corporation
Gastroenterology & Urology · 104d
Cleared Oct 22, 2015
WorkMate Claris System, WorkMate Claris System Display Plus
K151911 · DQK
St Jude Medical
Cardiovascular · 101d
Cleared Oct 22, 2015
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini...
K152096 · MPN
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Oct 22, 2015
PEAK
K152180 · ELW
Neosil Co., Ltd.
Dental · 79d
Cleared Oct 22, 2015
Pacel Bipolar Pacing Catheters
K152784 · LDF
St Jude Medical
Cardiovascular · 27d
Cleared Oct 21, 2015
ClearPoint System
K142505 · HAW
Mri Interventions, Inc.
Neurology · 411d
Cleared Oct 21, 2015
NuVasive VuePoint II OCT System
K150474 · NKG
Nu Vasive, Incorporated
Orthopedic · 240d
Cleared Oct 21, 2015
H-MAX S Femoral Hip System
K150855 · MEH
Lima Corporate S.P.A.
Orthopedic · 204d
Cleared Oct 21, 2015
Oregon Scientific
K151415 · DXN
Idt Technology Limited
Cardiovascular · 147d
Cleared Oct 21, 2015
ProTech Plus
K151646 · EBI
Protech Professional Products, Inc.
Dental · 125d
Cleared Oct 21, 2015
Philips IntelliVue GuardianSoftware
K151736 · DXJ
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 117d
Cleared Oct 21, 2015
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION...
K151836 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 107d
Cleared Oct 21, 2015
S4 Cervical Spinal and Occiput Systems
K151938 · NKG
Aesculap Implant Systems, LLC
Orthopedic · 99d
Cleared Oct 21, 2015
EVS 3643
K151942 · MQB
DRTECH Corporation
Radiology · 99d
Cleared Oct 21, 2015
Luminesse Anterior Zirconia AT
K152066 · EIH
Talladium, Inc.
Dental · 89d