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

KNW 2016-02-25

Mammotome revolve Dual Vacuum Assist Biopsy System

Applicant Devicor Medical Products, Inc.

K-Number K152989

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HRS 2016-02-25

IRENE Locking Compression Plate System

Applicant Tianjin Zhengtian Medical Instrument Co., Ltd.

K-Number K151508

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GEX 2016-02-25

SKIN CARE

Applicant C.I.S, Ltd.

K-Number K152736

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LYY 2016-02-25

LATEX EXAMINATION GLOVE POWDER FREE

Applicant Careplus (M) Sdn Bhd

K-Number K152593

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LZA 2016-02-25

HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR

Applicant Haining Medical Products Co., Ltd.

K-Number K152715

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OUP 2016-02-25

The Cellfina System

Applicant Ulthera, Inc.

K-Number K153677

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DQX 2016-02-25

ASAHI Astato XS 40

Applicant Asahi Intecc Co., Ltd.

K-Number K153443

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EMA 2016-02-25

EDS Universal Cement

Applicant Essential Dental Systems, Inc.

K-Number K152691

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LEJ 2016-02-25

High Pressure Tanning Lamps

Applicant Blv Licht-Und Vakuumtechnik GmbH

K-Number K152141

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LLZ 2016-02-25

MedicVOD System

Applicant Orpheus Medical , Ltd.

K-Number K151737

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QEY 2016-02-25

Occlusion Perfusion Catheter

Applicant Advanced Catheter Therapies, Inc.

K-Number K153488

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MUJ 2016-02-25

MRCAT

Applicant Philips Medical Systems MR Finland

K-Number K151435

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