BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    Zimmer Persona Personalized Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HALIFAX BIOMEDICAL TANATLUM BEAD SET

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

    EMBOZENE MICROSPHERES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 19, 2021

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 9, 2022

    ARCHITECT C8000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·July 23, 2011

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 17, 2013

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·October 15, 2014

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ22

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 13, 2018

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    RADIFOCUS GLIDEWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

    TERUMO RADIFOCUS GUIDE WIRE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018

    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·October 31, 2018

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024