BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    FAXITRON SPECIEN RADIOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857554092·Parallel Trial Size 12x30x11 mm

    QUANTITATIVE BLOOD POOL SPECT (QBS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    WUNDER TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IOLMASTER 500

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·May 21, 2013

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·September 18, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 13, 2011

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012

    PERITX DRAINAGE BAG KIT

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·December 18, 2025

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 11, 2026

    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024