BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Neurovascular Access System Family

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    inCoris ZI

    FDA UDI
    SIRONA Dental Systems GmbH·E27662407462·inCoris ZI maxi S F1 1 St/pcs.

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464057436·SONIC RADIANT 40 MNR T DG

    MRA-CMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    IPL Treatment Systems

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

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    FG6301 DUAL CHNL VOL INFUSIONPUMP, 2M8064 RECONDND

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 25, 2008

    HAUSTED VIC VIDEOFLUOROSCOPIC IMAGING CHAIR

    FDA Adverse Event
    HAUSTED PATIENT HANDLING SYSTEMS, LLC·Product code FZK·September 2, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 22, 2013

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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