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

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    AquaPulse Auxiliary Water Connector

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

    SM PLUS BTT/ROUND BALLOON DISSECTOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GCJ·October 24, 2014

    COLLEAGUE PRE-P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 1, 2013

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021