Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

JAA 2016-08-17

Uroview FD

Applicant Pausch Medical GmbH

K-Number K161019

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FRO 2016-08-17

LUOFUCON Silicone Ag foam dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K160022

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IMI 2016-08-17

Accent XL

Applicant Alma Lasers, Inc.

K-Number K160075

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LLZ 2016-08-17

PACS CORE/ENCORE

Applicant Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

K-Number K161518

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FLL 2016-08-16

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

Applicant Kaz USA, Inc., A Helen of Troy Company

K-Number K161933

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EZD 2016-08-16

PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C

Applicant Adapta Medical, Inc.

K-Number K161445

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GEX 2016-08-16

A.R.C. Laser Surgical Fibers and Probes

Applicant A.R.C Laser GmbH

K-Number K161403

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IMI 2016-08-16

MC1 Plus

Applicant General Project S.R.L.

K-Number K161502

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DZI 2016-08-15

Oral Surgery System and Accessories

Applicant Bonart Co., Ltd.

K-Number K152125

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HRS 2016-08-15

Tarsa-Link Stand-Alone Wedge Fixation System

Applicant Life Spine, Inc.

K-Number K161037

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DXO 2016-08-15

PressureWire X Guidewire

Applicant St. Jude Medical, Inc.

K-Number K161171

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HRS 2016-08-15

Distal Radius Plating System

Applicant Miami Device Solutions, LLC

K-Number K161292

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