BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209136186·

    E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE

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

    DOUBLE-SWIVEL CONNECTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 9, 2014

    SIGMA 300 DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·October 5, 2010

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·December 3, 2012

    GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·November 21, 2018

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, 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