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

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    VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SOMATOM DEFINITION AS

    FDA 510(k)
    FDA Class 2 ·Radiology

    MIRAGE QUATTRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOTAK RELIANCE SG

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NVY·January 1, 2022

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 21, 2013

    DUROM US ACETABULAR COMPONENT 58/52 R

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 6, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

    UNKNOWN HIP FEMORAL CONSTRUCT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·August 18, 2025

    UNK HIP FEMORAL HEAD CERAMIC

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 18, 2025

    UNKNOWN BIOPSY NEEDLE

    FDA Adverse Event
    Injury ·COVIDIEN LP - SUPERDIMENSION INC·Product code GAA·March 20, 2023

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Injury ·COVIDIEN LP - SUPERDIMENSION INC·Product code JAK·March 20, 2023

    UNKNOWN CYTOLOGY BRUSH

    FDA Adverse Event
    Injury ·COVIDIEN LP - SUPERDIMENSION INC·Product code FDX·March 7, 2023

    UNKNOWN HIP ACETABULAR CONSTRUCT DURALOC

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·August 18, 2025

    UNK HIP ACETABULAR LINER CERAMIC

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 18, 2025

    UNK HIP ACETABULAR CUP DURALOC

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL LTD - 8010379·Product code LPH·August 18, 2025

    UNKNOWN HIP FEMORAL STEM

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 29, 2025

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 20, 2015

    STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·May 8, 2013

    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·August 8, 2012