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

KTT 2020-12-08

Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation

Applicant Smith & Nephew

K-Number K201253

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FDT 2020-12-08

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

Applicant Olympus Medical Systems Corp.

K-Number K202661

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NHA 2020-12-08

CARES Screw - Retained Bars and Bridges (SRBB)

Applicant Medentika GmbH

K-Number K201711

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LYA 2020-12-08

Novapak Nasal Sinus Packing and Stent

Applicant Medtronic Xomed

K-Number K202623

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KWD 2020-12-08

Accu-Joint Hemi Implant

Applicant Accufix Surgical, Inc.

K-Number K200951

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GDW 2020-12-07

GIA Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K202701

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DPS 2020-12-07

B-Secur HeartKey Software Library

Applicant B-Secur , Ltd.

K-Number K200884

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HEB 2020-12-07

Callaly Tampliner

Applicant Calla Lily Personal Care, Ltd.

K-Number K201003

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QKM 2020-12-07

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator

Applicant 3M Company

K-Number K203284

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FLL 2020-12-07

YUWELL Infrared Thermometer

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K-Number K201864

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DQA 2020-12-07

Pulse Oximeter

Applicant Shenzhen Raysintone Technology Co., Ltd.

K-Number K201384

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HQF 2020-12-07

Ophthalmic Yag Laser System YC-200

Applicant Nidek Co., Ltd.

K-Number K203130

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