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

MNR 2017-02-24

Watch-PAT200U

Applicant Itamar Medical , Ltd.

K-Number K161579

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KCT 2017-02-23

Medtronic Transportation/Sterilization Cassettes

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K163279

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LYZ 2017-02-23

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)

Applicant Hebei Hongtai Plastic Products Company Limited

K-Number K163168

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IRP 2017-02-23

Pressure Therapy System

Applicant Xiamen Senyang Co., Ltd.

K-Number K161907

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HBL 2017-02-23

TZ SKULL PIN Adult

Applicant Tz Medical, Inc.

K-Number K163322

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GGN 2017-02-23

George King Coumadin Plasma

Applicant George King Bio-Medical, Inc.

K-Number K161316

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MBI 2017-02-23

GRAVITYTM PEEK-OPTIMA Suture Anchor

Applicant Wrightmedicaltechnologyinc

K-Number K170265

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PRI 2017-02-23

VIDAS B.R.A.H.M.S. PCT (PCT)

Applicant bioMerieux, Inc.

K-Number K162827

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MUE 2017-02-23

RSM 1824C with RConsole1

Applicant DRTECH Corporation

K-Number K162670

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EFB 2017-02-23

Air-Powered Handpieces and Handpiece Attachments

Applicant W&H Dentalwerk Burmoos GmbH

K-Number K162926

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PRH 2017-02-23

Accelerate Pheno system, Accelerate Phenotest BC Kit

Applicant Accelerate Diagnotics

K-Number DEN160032

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JWH 2017-02-23

Truliant Femoral Components

Applicant Exactech, Inc.

K-Number K170240

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