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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    DINABASE (TM)

    FDA 510(k)
    FDA Class 2 ·Dental

    Nexus DR Digital X-ray Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code MBI·April 27, 2012

    FX OXY W/HR & ART FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION·Product code DTZ·April 29, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN FORMERLY NELLCOR·Product code CBK·February 1, 2013

    YUME SET FOR UV FLASH

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SINGAPORE·Product code KDJ·January 26, 2011

    Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer bassinet during normal and intensive care - For infant re-warming and compensation of heat loss - For thermal stabilizing of infants with mattress heater (Babytherm 8010 only) - For gentle warming therapy using the combination of radiant and mattress heater - Cooling infants with fever (temperature of mattress below infant body temperature, Babytherm 8010 only) - With adjustable bed tilt for treatment of infants in Trendelenburg and reverse Trendelenburg position - For weaning infants from incubators - For O2 and nebulizer therapy (with appropriate accessories) - For lowering an infant s bilirubin levels when using the phototherapy option

    FDA Enforcement
    Class II ·Terminated·Draeger Medical, Inc.·August 3, 2016

    Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer bassinet during normal and intensive care - For infant re-warming and compensation of heat loss - For thermal stabilizing of infants with mattress heater (Babytherm 8010 only) - For gentle warming therapy using the combination of radiant and mattress heater - Cooling infants with fever (temperature of mattress below infant body temperature, Babytherm 8010 only) - With adjustable bed tilt for treatment of infants in Trendelenburg and reverse Trendelenburg position - For weaning infants from incubators - For O2 and nebulizer therapy (with appropriate accessories) - For lowering an infant s bilirubin levels when using the phototherapy option

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FMT·June 22, 2016