BEUDAMED
    30 results · 24ms · Sources: EU EUDAMED, US FDA

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    X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Zavation

    FDA UDI
    Zavation LLC·00197157002718·CIF 14x18, 6 deg, -11

    ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE

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

    MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CADD SOLIS VIP PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·May 28, 2022

    MPACT ACETABULAR SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 23, 2026

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 6, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 1, 2011

    COULTER® LH 500 HEMATOLOGY INSTRUMENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 16, 2013

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 13, 2024

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 13, 2025

    MPACT ACETABULAR SYSTEM IMPLANTS

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LPH·November 5, 2025

    MPACT ACETABULAR SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 18, 2025

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 27, 2025

    AMISTEM-P COLLARED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 14, 2025

    MPACT ACETABULAR SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 6, 2026

    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023

    QUADRA P FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 23, 2026

    AMISTEM-P COLLARED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 2, 2024

    AMISTEM-P COLLARED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 22, 2025