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

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    ASSAY KIT, THROMBO-SCREEN

    FDA 510(k)
    FDA Class 2 ·Hematology

    VivaSight-SL (TVT) system

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ATLAS SPINE SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPEEDICATH COMPACT MALE

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code GBM·October 29, 2021

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·April 30, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 5, 2012

    ENDOPATH ETS

    FDA Adverse Event
    ETHICON ENDO-SURGERY LLC·Product code GDW·July 27, 2010

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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