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

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    Treace Medical Concepts (TMC) Compression Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELECSYS RUBELLA IGG IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AUDIT MICROCV CARDIAC MARKERS LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GLOBAL ADVANTAGE CTA HD 52X18

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSD·July 19, 2011

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·June 17, 2013

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·September 19, 2008

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 3, 2020

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 2, 2020

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 7, 2020

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 30, 2022

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 30, 2022

    BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 31, 2023

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 2, 2020

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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