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

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    Masimo Rad-97 Pulse CO-Oximeter and Accessories

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INNOVANCE D-DIMER, MODEL OPBP09

    FDA 510(k)
    FDA Class 2 ·Hematology

    CUTERA GENESISPLUS LASER SYSTEM

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

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 22, 2014

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 25, 2013

    MTS ABD/ABD MONOCLONAL BLOOD GROUPING CARD

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·August 5, 2011

    ELITE IQ

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 4, 2024

    ELITE IQ

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 6, 2024

    ELITE IQ

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 25, 2025

    ELITE IQ

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·September 21, 2021

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 28, 2022

    ELITE IQ

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 21, 2026

    INNOVANCE D-DIMER

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code DAP·July 14, 2017

    ELITE IQ

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·December 17, 2021

    ELITE IQ

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 13, 2022

    ELITE IQ

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·September 16, 2025

    ELITE IQ

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 20, 2022

    ELITE IQ

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 4, 2022

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025