BEUDAMED
    17 results · 35ms · Sources: EU EUDAMED, US FDA

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    CENTURY SAF-LIFT & SAF-KARY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ERA® Lock Cement .5 grams

    FDA UDI
    STERNGOLD DENTAL LLC·00841549102653·An auto-curing, filled, composite resin cement.

    SteriChek® Residual Chlorine Reagent Strips

    FDA UDI
    HACH COMPANY·00851575007020·Reagent test strip for measuring the concentrat...

    NA

    FDA UDI
    aap Implantate AG·04042409042546·Double drill guide ø2.0/2.7

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172974001·UniTip High Resolution Catheter 8F

    GLUCOSE (HEXOKINASE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER

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

    INTELLIVUE INFO CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 1, 2024

    EMERGE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 15, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 30, 2007

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·October 31, 2012

    REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 6, 2023

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; 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