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

LQR 2017-11-27

Single Use Retrieval Nitinol Basket V

Applicant Olympus Medical Systems Corp.

K-Number K170811

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GXQ 2017-11-27

Cerafix Dura Substitute

Applicant Acera Surgical, Inc.

K-Number K172603

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HRS 2017-11-27

CoLink View Plating System

Applicant In2bones USA, LLC

K-Number K172300

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MAI 2017-11-27

HEALIX ADVANCE KNOTLESS Anchor

Applicant Medos International SARL

K-Number K171114

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MCW 2017-11-27

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K-Number K172687

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HWC 2017-11-27

VariAx 2 System

Applicant Stryker GmbH

K-Number K173135

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EBZ 2017-11-27

LED Curing Light

Applicant Monitex Industrial Co., Ltd.

K-Number K161855

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NHA 2017-11-27

Straumann Screw Retained Abutments

Applicant Straumann USA, LLC (On Behalf of Institut Straumann Ag)

K-Number K171757

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PMN 2017-11-24

FilmArray RP2/RP2plus Control Panel

Applicant Maine Molecular Quality Controls, Inc.

K-Number K173171

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KCT 2017-11-24

SALUS - Hygiene Instrument Reprocessing Container

Applicant Scican , Ltd.

K-Number K172292

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GZL 2017-11-24

DIXI Medical Microdeep Depth Electrode

Applicant Dixi Medical

K-Number K170959

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OLO 2017-11-24

ExactechGPS Total Shoulder Application

Applicant Blue Ortho

K-Number K173372

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