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

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    OREIA-T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AZUR

    FDA UDI
    Microvention, Inc.·00816777024398·Azur CX Detachable

    Azur

    FDA UDI
    Microvention, Inc.·00842429119174·Azur CX Detachable

    COIL EMBL 8CM 3MM AZUR CX

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CANADA, INC.·Product code KRD·June 30, 2023

    Prelude

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD

    FDA 510(k)
    FDA Class 2 ·Dental

    COIL EMBL 2CM 2MM AZUR CX

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CANADA, INC.·Product code KRD·June 30, 2023

    COIL EMBL 4CM 2MM AZUR CX

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CANADA, INC.·Product code KRD·June 30, 2023

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2012

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·July 26, 2010

    AZUR CX 18D-LONGER

    FDA Adverse Event
    Malfunction ·MICROVENTION INC.·Product code KRD·September 11, 2024

    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

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025