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

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    CrossCath Support Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CROSSCATH SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 6, 2019

    CROSSCATH SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·February 26, 2019

    CROSSCATH SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·June 20, 2019

    ers2 Basic Software

    FDA UDI
    ergoline GmbH·04059358001838·

    Cardiovascular Procedure Kit

    FDA UDI
    Terumo Cardiovascular Systems Corporation·50699753465423·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528103999·ExtremiFix Mid, 4.5mm/5.5 mm Screw System Tray Lid

    2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MONICA AN24

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·June 6, 2013

    INTERSTIM

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·July 8, 2011

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·October 10, 2014

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    CAREFUSION SMARTSITE EXTENSION

    FDA Adverse Event
    Injury ·CAREFUSION·Product code FPA·February 1, 2018

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020