BEUDAMED
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    SHILEY CRICOTHYROTOMY TUBE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Azur CX Detachable

    FDA UDI
    Microvention, Inc.·00810170018381·Azur

    Azur CX Detachable

    FDA UDI
    Microvention, Inc.·00810170017575·Azur

    Azur

    FDA UDI
    Microvention, Inc.·00842429119273·Azur CX Detachable

    Panta 2 Arthrodesis Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ICSI CUMULASE

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

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·April 30, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 10, 2012

    XXL BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·August 3, 2010

    Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    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