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

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    VITEK MS PRIME

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RHYTHMIA MAPPING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER

    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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    AMS 700 INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·August 11, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·July 9, 2013

    RAD-97 PULSE CO-OXIMETER

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

    INTELLAMAP ORION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023