BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    ANGIOSCULPT PTA SCORING BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 5, 2021

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·May 25, 2011

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021