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

KNS 2016-03-17

Rezum System

Applicant Nxthera, Inc.

K-Number K160417

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PLO 2016-03-17

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch

Applicant Biofire Diagnostics, LLC

K-Number K160462

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MWI 2016-03-17

Axeo 3 Patient Monitor

Applicant Axeo Medical Technologies, LLC

K-Number K153079

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LZA 2016-03-17

Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color

Applicant Jiayuan Medical Products Co., Ltd.

K-Number K152705

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FMZ 2016-03-17

Giraffe OmniBed Carestation CS1

Applicant Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company

K-Number K152814

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GXQ 2016-03-16

Cerafix Dura Substitute

Applicant Acera Surgical, Inc.

K-Number K153613

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LLZ 2016-03-16

Vitrea CT Colon Analysis

Applicant Vital Images, Inc.

K-Number K160150

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IYN 2016-03-16

FUJIFILM FC1 Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K160406

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OVE 2016-03-16

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

Applicant Renovis Surgical Technologies

K-Number K153250

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MAX 2016-03-16

SUSTAIN Additional Implants

Applicant Globus Medical, Inc.

K-Number K151665

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LLZ 2016-03-16

Xeleris 4.0 Processing and Review Workstation

Applicant GE Healthcare

K-Number K153355

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GFO 2016-03-16

HemosIL Silica Clotting Time

Applicant Instrumentation Laboratory CO

K-Number K160445

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