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

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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GGN 2017-06-21

VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

Applicant Maine Standards Company, LLC

K-Number K170864

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HWC 2017-06-20

Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw

Applicant Tyber Medical, LLC

K-Number K170571

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PEM 2017-06-20

Premium Plus Disposable Barrier Sleeve

Applicant Premium Plus International Limited

K-Number K163447

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LZO 2017-06-20

Corin MetaFix Hip Stem

Applicant Corin U.S.A. Limited

K-Number K162942

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FRC 2017-06-20

STERRAD VELOCITY Biological Indictator and Reader

Applicant Advanced Sterilization Products (Asp)

K-Number K170039

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BZC 2017-06-20

COSMED K5 Wearable Metabolic Technology

Applicant Cosmed Srl

K-Number K162515

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