BEUDAMED
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    TELEMETRY SYSTEM, BIOTEL 300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Azur CX Detachable

    FDA UDI
    Microvention, Inc.·00810170018398·Azur

    Azur CX Detachable

    FDA UDI
    Microvention, Inc.·00810170017582·Azur

    Azur

    FDA UDI
    Microvention, Inc.·00842429119280·Azur CX Detachable

    4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DURATA STS OPTIM ACTIVE FIXATION

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 11, 2012

    OSCILLATING BONE SAW

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HWE·May 19, 2015

    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