BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    HIP, FEMUR AND HUMERUS RETRACTOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Vivid Electrode Tip #14

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724B8805100·

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457210153·Internal Hex "Click"

    ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MC3 Jugular Dual Lumen Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 22, 2010

    CURRENT PLUS DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·December 19, 2012

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020