BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    AQUA-GEL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Azur CX Detachable

    FDA UDI
    Microvention, Inc.·00810170017544·Azur

    Azur CX Detachable

    FDA UDI
    Microvention, Inc.·00810170018350·Azur

    Azur

    FDA UDI
    Microvention, Inc.·00842429119242·Azur CX Detachable

    TR-USB TELEPHONIC STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Halcyon

    FDA 510(k)
    FDA Class 2 ·Radiology

    SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·April 30, 2014

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 10, 2012

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 26, 2007

    Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·November 13, 2013

    Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, MV-AX80304CL, MV-AX80308CL, MV-AX80413CL, MV-AX80516CL, MV-AX80620CL, MV-AX80724CL, MV-AX80828CL, MV-AX80928CL, MV-AX81032CL, MV-AX81238CL, MV-AX81434CL, MV-AX81639CL, and MV-AX82040CL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Recall
    Terminated ·Microvention, Inc.·Product code KRD·November 24, 2019

    Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, MV-AX80304CL, MV-AX80308CL, MV-AX80413CL, MV-AX80516CL, MV-AX80620CL, MV-AX80724CL, MV-AX80828CL, MV-AX80928CL, MV-AX81032CL, MV-AX81238CL, MV-AX81434CL, MV-AX81639CL, and MV-AX82040CL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020