BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    Dermalux Tri-Wave MD

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CALIPER CASTROVIEJO 40mm FENSTRATED

    FDA UDI
    W.H. Holden, Inc.·D9282006590·

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120065900000·Curved Pedicle Probe

    DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT

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

    MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COCR HEAD 28/+4 'L' 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code MEH·January 26, 2026

    LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 11, 2023

    MILLER BONE CEMENT INJECTOR FRONT LOADING CARTRIDGE KIT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KIH·October 17, 2008

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    PATIENT INTERFACE NIM4CPB1 NIM 4.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025

    STIMULATOR, ELECTRICAL, EVOKED RESPONSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 31, 2023

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·September 5, 2025

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·August 2, 2024

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 20, 2025

    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