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

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    MG II POROUS COBAL T-CHROME FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACUITY

    FDA Adverse Event
    Death ·CPI - DEL CARIBE·Product code OJX·January 11, 2013

    PFC CVD 8MM SZ5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 29, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 3, 2014

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025