BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    COSMED PONY FX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)

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

    OPART, MODEL MRT-600

    FDA 510(k)
    FDA Class 2 ·Radiology

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 9, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 18, 2011

    LEAD MODEL 302

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·May 9, 2008

    3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM

    FDA Adverse Event
    Injury ·SYNTHES PRODUKTIONS GMBH·Product code NKG·February 8, 2018

    LOCKSCR SYNAPSE TAN

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018

    LOCKSCR SYNAPSE TAN

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013