BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    Viola

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

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721070·Buck Ear Curette 6-1/2" (16.3cm), size 3, sharp...

    Cascade Pro

    FDA UDI
    CADWELL INDUSTRIES, INC.·00840067100165·Cascade Pro Base

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306804434·Woodson Elevator 18cm

    T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEMOSIL D-DIMER HS 500, CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 20, 2024

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·October 9, 2008

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 10, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    EARLYVUE VS30 VITALS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021

    EARLYVUE VS30 VITALS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021

    SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019