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
33721–33744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2015
BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit
K152870 · PSZ
Becton, Dickinson and Co.
Microbiology · 27d
Cleared Oct 27, 2015
BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
K152874 · PSZ
Becton, Dickinson and Co.
Microbiology · 27d
Cleared Oct 27, 2015
SIGNA Pioneer
K153003 · LNH
Ge Healthcare
Radiology · 14d
Cleared Oct 26, 2015
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set,...
K150270 · MRG
Tosoh Bioscience, Inc.
Chemistry · 264d
Cleared Oct 26, 2015
LiquiBand Exceed
K151182 · MPN
Advanced Medical Solutions...
General & Plastic Surgery · 175d
Cleared Oct 26, 2015
Retrieval bag system
K151489 · GCJ
Beacon Surgical, Inc.
General & Plastic Surgery · 146d
Cleared Oct 26, 2015
Varian Treatment (VTx)
K151882 · IYE
Varian Medical Systems, Inc.
Radiology · 109d
Cleared Oct 26, 2015
Volpara Imaging Software
K152028 · LLZ
Matakina Technologies Limited
Radiology · 96d
Cleared Oct 26, 2015
Resection Electrodes
K152092 · FAS
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 90d
Cleared Oct 26, 2015
PolarCath Peripheral Dilatation System
K152665 · LIT
Nucyro Vascular, LLC
Cardiovascular · 39d
Cleared Oct 23, 2015
RF20000a Controller, FLOW 50 Wand
K143235 · GEI
ArthroCare Corporation
General & Plastic Surgery · 347d
Cleared Oct 23, 2015
ICS CHARTR EP 200 WITH VEMP
K143670 · GWJ
Gn Otometrics A/S
Neurology · 303d
Cleared Oct 23, 2015
Orthodontics Bracket
K150141 · NJM
Speed Dental Co., Ltd.
Dental · 274d
Cleared Oct 23, 2015
Medentika CAD/CAM Abutments
K150203 · NHA
Medentika GmbH
Dental · 267d
Cleared Oct 23, 2015
FEMTO LDV Z8 Surgical Laser
K150323 · OOE
Sie Ag,Surgical Instrument Engineering
Ophthalmic · 256d
Cleared Oct 23, 2015
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug...
K150606 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 227d
Cleared Oct 23, 2015
SureClip
K150936 · FZP
Conmed Corporation
General & Plastic Surgery · 199d
Cleared Oct 23, 2015
LightStim Professional 2-Panel Light
K151336 · OHS
Led Intellectual Properties, LLC
General & Plastic Surgery · 157d
Cleared Oct 23, 2015
Cellvizio 100 Series System with Confocal Miniprobes
K151593 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 133d
Cleared Oct 23, 2015
R-40 EEG Amplifier
K151600 · GWL
Lifelines , Ltd.
Neurology · 133d
Cleared Oct 23, 2015
ER-REBOA Catheter
K151821 · DQY
Pryor Medical Devices, Inc.
Cardiovascular · 109d
Cleared Oct 23, 2015
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
K152106 · OAS
VATECH Co., Ltd.
Radiology · 86d
Cleared Oct 23, 2015
Vantage Titan 3T
K152371 · LNH
Toshibamedical Systems Corporation
Radiology · 63d
Cleared Oct 23, 2015
Avitus Bone Harvester
K152474 · KNW
Avitus Orthopaedics, Inc.
Gastroenterology & Urology · 53d