BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    DIEGO ELITE DRILL

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

    AGC V2 TOTAL KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304242371·

    SAPIENS TIP CONFIRMATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    C2000 AUTOMATED MANIFOLD KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PASSEO-18 5/200/90

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

    PASSEO-18 6/200/90

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

    PASSEO-18 2.5/170/130

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    TERUMO CDI 540 CALIBRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·June 24, 2011

    ALLEVYN LIFE S 10.3X10.3 CTN10

    FDA Adverse Event
    Injury ·SMITH & NEPHEW MEDICAL LTD.·Product code NAD·October 15, 2015

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 12, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 27, 2016

    VARIABLE SELF-DRILLING SCREW DIAM. 4X14MM (2X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·October 4, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 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