BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    I-GLIDE IOL IMPLANTATION AID

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    IPL Hair Removal Device

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

    EPT CERTAINTY PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RECEPTAL CANISTER 1000 ML CE

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL CO., LTD.·Product code GCX·May 25, 2012

    RECEPTAL 1.5LITER PE/CE WITH (50/CASE)

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code GCX·August 1, 2011

    NON-PVC RECEPT LINER 2000ML/CE(50/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD.·Product code GCX·June 21, 2011

    NON-PVC RECEPT. LINER 2000ML/CE(50/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD.·Product code GCX·June 21, 2011

    NON-PVC RECEPT LINER 2000ML/CE(50/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD.·Product code GCX·June 21, 2011

    RECEPTAL 1.5 LITER PE/CE WITH (50/CASE)

    FDA Adverse Event
    Injury ·HOSPIRA LTD.·Product code GCX·November 18, 2010

    RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code GCX·June 24, 2011

    RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code GCX·June 24, 2011

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·November 15, 2012

    GEMSTAR PAIN MGE SNG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 26, 2014

    REVEAL LINQ

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code DSI·June 10, 2015

    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