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

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    Medartis APTUS® Ulna Plates

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K-ASSAY LP(A) CONTROLS

    FDA 510(k)
    FDA Class 2 ·Immunology

    VIVASIGHT-DL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X380MM X 12

    FDA Adverse Event
    Injury ·STRYKER TRAUMA GMBH·Product code HSB·October 30, 2012

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·November 27, 2018

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 4, 2014

    ROTATABLE SNARE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA·Product code FDI·August 26, 2011

    INVIZIA 2-LEVEL ACDF PLATE - 42MM

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code KWQ·July 10, 2013

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·August 23, 2018

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·March 8, 2018

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·March 8, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026