BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ESKA JONAS SILICONE-SILVER PENILE PROST

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209135851·

    NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORE-SPORT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2012

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·December 11, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 23, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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