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

KWY 2017-02-07

Fitmore® Hip Stem

Applicant Zimmer GmbH

K-Number K170072

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FGE 2017-02-07

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

Applicant Cook Ireland, Ltd.

K-Number K163169

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LZA 2017-02-06

NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE

Applicant Hartalega NGC Sdn. Bhd.

K-Number K162923

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LLZ 2017-02-06

UC-CARE NaviGo Workstation

Applicant UC-CARE , Ltd.

K-Number K160934

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NDN 2017-02-06

DCM Kyphoplasty System

Applicant Dragon Crown Medical Co., Ltd.

K-Number K162283

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KWQ 2017-02-06

Altus Spine Cervical Plate System

Applicant Altus Partners, LLC

K-Number K163061

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NAY 2017-02-06

EndoWrist Suction Irrigator

Applicant Intuitive Surgical, Inc.

K-Number K162973

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LLZ 2017-02-06

syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163294

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DQA 2017-02-06

Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)

Applicant Bluepoint Medical GmbH & Co. KG

K-Number K162014

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EMA 2017-02-06

3M Protemp Cement Temporary Dental Cement

Applicant 3M Company

K-Number K170330

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NXC 2017-02-03

MTM Clear Aligner

Applicant Dentsply Sirona

K-Number K163155

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LJS 2017-02-03

PICC Maximal Barrier Nursing Kit

Applicant Navilyst Medical, Inc.

K-Number K163452

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