BEUDAMED
    20 results · 31ms · Sources: EU EUDAMED, US FDA

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    Direct HDL Cholesterol (HDL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111073434·SKLHN MAYO SCISS CVD SERR 9"

    GE VOLUSON I

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code OVD·November 13, 2019

    POWER DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code GEY·October 8, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 8, 2013

    STELLARIS OPTIMIZED STABILITY VACUUM PACK

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQC·June 21, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    DYB INTRODUCER, CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·November 12, 2025

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·September 15, 2020

    ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·April 23, 2019

    ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·January 27, 2023

    ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·May 13, 2023

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·February 7, 2020

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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