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

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    URO-FLO

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

    SATLITE PLUS PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRIMARY DRESSING TRAY

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

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

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 18, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·December 28, 2012

    ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 48-17, R=26.8MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSD·June 23, 2020

    ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 48-17, R=26.8MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSD·June 23, 2020

    ANATOMICAL SHOULDER, HUMERAL STEM, CEMENTED, 12, 100 MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWS·June 23, 2020

    MEDEX LOGICAL PRESSURE MONITORING SYSTEM

    FDA Adverse Event
    Death ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code DRS·June 29, 2020

    MEDEX LOGICAL PRESSURE MONITORING SYSTEM

    FDA Adverse Event
    Death ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code DRS·June 29, 2020

    MEDEX LOGICAL PRESSURE MONITORING SYSTEM

    FDA Adverse Event
    Death ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code DRS·June 29, 2020

    ANATOMICAL SHOULDER DOMELOCK , DOME, CENTRIC

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWS·June 26, 2020

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015

    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·October 15, 2014

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015