BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MEDCOMP ASH SPLIT

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

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·January 15, 2019

    STERIS SYSTEM 1E

    FDA Adverse Event
    STERIS CORPORATION - HOPKINS·Product code MED·March 26, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·March 8, 2011

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, DR·Product code DYG·March 24, 2008

    PX SLIM DELIVERY MICROCATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·November 22, 2019

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·November 22, 2019

    Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 28, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014