BEUDAMED
    8 results · 24ms · Sources: EU EUDAMED, US FDA

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    Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113233·VITRECTOMY KNIFE 19GA (BX/5)

    HYPERION LONG PULSED ND: YAG LASER

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

    CALCIGEN PSI BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERIMOUNT MAGNA EASE AORTIC SIZER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DTI·November 5, 2008

    ESSURE

    FDA Adverse Event
    Injury ·ESSURE·Product code HHS·August 27, 2011

    RADIOFREQUENCY NITINOL PROBE-CURVED

    FDA Adverse Event
    Other ·BAYLIS MEDICAL CO., INC.·Product code GXI·July 12, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025