BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIMMETRY SACROILIAC JOINT FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANSPACH POWERED KERRISON SYSTEM (PKS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    CODA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·October 23, 2017

    IVT DIPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·May 21, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 26, 2014

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 14, 2011

    CODA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·September 10, 2019

    DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·August 10, 2023

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024