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

GEI 2016-02-26

THUNDERBEAT Open Fine Jaw

Applicant Olympus Medical Systems Corp.

K-Number K151743

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LZO 2016-02-26

ICONACY(TM) I-Hip (TM)

Applicant Iconacy Orthopedic Implants, LLC

K-Number K151307

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PHL 2016-02-26

Indego

Applicant Parker Hannifin Corporation

K-Number K152416

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GEX 2016-02-26

Novilase Laser Therapy System, Model LTS-2

Applicant Novian Health, Inc.

K-Number K160392

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DTZ 2016-02-26

TandemLung Oxygenator

Applicant Cardiacassist, Inc.

K-Number K153295

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FRC 2016-02-26

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

Applicant Bcr Diagnostics, Inc.

K-Number K151482

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DXK 2016-02-26

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

Applicant Boston Scientific Corporation

K-Number K160173

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MQB 2016-02-26

VIVIX-S 1717N

Applicant Vieworks Co., Ltd.

K-Number K152894

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PMV 2016-02-26

Beactive Brace

Applicant Natures Pillows, Inc.

K-Number K151476

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MQB 2016-02-26

VIVIX-S 1012N

Applicant Vieworks Co., Ltd.

K-Number K152855

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DTK 2016-02-26

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM

Applicant B. Braun Interventional Systems, Inc.

K-Number K152765

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MWJ 2016-02-26

H3+ Holter Recorder

Applicant Mortara Instrument, Inc.

K-Number K152626

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