Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

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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DZE 2016-03-16

NobelZygoma 45°

Applicant Nobel Biocare AB

K-Number K152093

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HRX 2016-03-16

SPINAUT-V, SPINAUT-S, SPINAUT-I

Applicant Imedicom Co., Ltd.

K-Number K151268

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HBE 2016-03-16

DReal

Applicant Carevature Medical, Ltd.

K-Number K153519

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PEN 2016-03-15

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch

Applicant Biofire Diagnostics, LLC

K-Number K160457

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LJT 2016-03-15

Dignity Dual Port

Applicant Medcomp ( Medical Components)

K-Number K153238

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