BEUDAMED
    10 results · 35ms · Sources: EU EUDAMED, US FDA

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    API UNISCEPT KB/TYPE 2 AND 3

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SUREFLEX STEERABLE GUIDING SHEATH KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 9, 2010

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 18, 2013

    SYNCHROMED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 9, 2014

    IMMULITE 2000 ESTRADIOL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024

    IMMULITE 2000 ESTRADIOL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024

    IMMULITE 2000 ESTRADIOL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021