Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

MQB 2017-05-15

EVS 2430W, EVS 2430GW

Applicant DRTECH Corporation

K-Number K171137

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SEL 2017-05-15

3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

Applicant 3M Company

K-Number K153410

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GEX 2017-05-15

Dental 5 Multi Diode laser

Applicant Bio-Med USA, Inc.

K-Number K163638

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OHV 2017-05-15

ULTRASHAPE POWER SYSTEM

Applicant Syneron Medical, Ltd.

K-Number K170370

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JAK 2017-05-15

SPiN Thoracic Navigation System

Applicant Veran Medical Technologies, Inc.

K-Number K170023

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HIF 2017-05-15

PNEUMOCLEAR

Applicant W.O.M. World of Medicine GmbH

K-Number K170784

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HBC 2017-05-15

IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools

Applicant Medtronic Powered Surgical Solutions

K-Number K170312

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KHE 2017-05-14

Wondfo One Step Fecal Occult Blood (FOB) Test

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K-Number K162333

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NDY 2017-05-12

N Latex Cystatin C; N Protein Standard UY

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K171072

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MWI 2017-05-12

Unity Network ID

Applicant GE Healthcare

K-Number K170199

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MQL 2017-05-12

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

Applicant Genea Biomedx Pty, Ltd.

K-Number K161261

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HRS 2017-05-12

Piccolo Composite® Plate System

Applicant CarboFix Orthopedics , Ltd.

K-Number K170401

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