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

NBY 2017-06-21

GOLNIT Non-Absorbable PTFE Surgical Suture

Applicant Antarma Dba Golnit Sutures

K-Number K163049

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FTM 2017-06-21

Biodesign Fistula Plug

Applicant Cook Biotech Incorporated

K-Number K170016

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OBO 2017-06-21

PRIMUS

Applicant Carl Zeiss Suzhou Co., Ltd.

K-Number K163195

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IZL 2017-06-21

DRX-Revolution Nano Mobile X-ray System

Applicant Carestream Health, Inc.

K-Number K170755

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FPA 2017-06-21

Solution Set with 1.2 Micron Air Eliminating Filter

Applicant Baxter Healthcare Corporation

K-Number K161808

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OGZ 2017-06-21

TVC Imaging System, TVC Catheter

Applicant Infraredx, Inc.

K-Number K163345

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LON 2017-06-21

VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)

Applicant bioMerieux, Inc.

K-Number K162737

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KWQ 2017-06-21

Terrace Anterior Cervical Plate System

Applicant Corelink, LLC

K-Number K163104

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IYN 2017-06-21

Venue

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K170714

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NFJ 2017-06-21

Retina Workplace

Applicant Carl Zeiss Meditec, AG

K-Number K170638

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NOY 2017-06-21

Embosphere Microspheres

Applicant Biosphere Medical, S.A.

K-Number DEN160040

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GGN 2017-06-21

VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

Applicant Maine Standards Company, LLC

K-Number K170864

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