BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    StrokeSENS LVO

    FDA 510(k)
    FDA Class 2 ·Radiology

    Packed 5D Plus US Scanning Unit, RMA

    FDA UDI
    Align Technology, Inc.·00816063021018·Wand RMAs

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982152459·5.0MM LCKNG SCREW SLF-DRLG W/T25 STARDRIVE RECE...

    Axis Charcot Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EnSite X EP System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·November 7, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 11, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 22, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    ADAPTA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·August 15, 2011

    O.B NON-APPLICATOR TAMPONS

    FDA Adverse Event
    Malfunction ·MONTREAL SAN PRO·Product code HEB·July 9, 2013

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 11, 2023

    QUATERA 700 BIMANUAL I/A HANDPIECE SET

    FDA Adverse Event
    Injury ·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023

    RAD-97 PULSE CO-OXIMETER WITH NOMOLINE CAPNOGRAPHY

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 12, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 15, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 5, 2023

    ALIYA

    FDA Adverse Event
    Injury ·NEAUVIA NORTH AMERICA, INC·Product code GEX·May 5, 2026

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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