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

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    SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    F20

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TROJAN PASSION BERRY GEL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    IMPAX CV OUTBOUND (RESULTS MGMT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    RENAISSANCE 26 P-WASS 10/04

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 15, 2013

    REVACLEAR

    FDA Adverse Event
    Injury ·Product code KDI·May 29, 2011

    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