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

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    Diode Laser Therapy Machine

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

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    Oticon

    FDA UDI
    Oticon A/S·05707131305268·SENSEI PRO, BTE 13 WL 90 PPI TAR

    PARTIAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSX·April 20, 2023

    TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC

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

    PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARTIAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSX·July 25, 2022

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Death ·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013

    ABL800 FLEX

    FDA Adverse Event
    Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·March 24, 2011

    Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021