BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    CHOCOLATE AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209105007·KIT, HIGH RISK

    BIOLOX DELTA CERAMIC FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    maxFit II Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 5, 2014

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 29, 2012

    MAYFIELD

    FDA Adverse Event
    INTEGRA LIFESCIENCES·Product code HBL·September 29, 2010

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015