BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    XTRAFIX EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXTENSION SET WITH T-CONN. SL

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·October 3, 2013

    TEMPORARY PACING WIRE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code LDF·May 15, 2013

    GYNECARE X-TRACT MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON·Product code HET·June 3, 2011

    STRATUS CS STAT FLUOROMETRIC ANALYZER

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 8, 2008

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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