BEUDAMED
    8 results · 35ms · Sources: EU EUDAMED, US FDA

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    SIGMA 59-UV FOR ALANINE AMINOTRANSFER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEMOR-RITE CRYOTHERAPHY

    FDA 510(k)
    FDA Unclassified ·Unknown

    JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)

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

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·January 21, 2025

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 22, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 21, 2012

    E500 VENTILATOR

    FDA Adverse Event
    Other ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·September 14, 2010

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026