BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019

    MODIFICATION TO VERTE-STACK SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G-CINCH SUTURE GRASPER

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

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 8, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 17, 2011

    GE OEC 6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 10, 2008

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    NESTER PLATINUM EMBOLIZATION MICROCOIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    STAINLESS STEEL EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·August 24, 2017

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022