BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    UNIQUET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SCANX 10

    FDA 510(k)
    FDA Class 2 ·Radiology

    TIPI OTC

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

    EXCOR BLOOD PUMP PU VALVES 10 ML, IN/OUT 6MM

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·June 3, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·January 28, 2013

    PUMP MMT-723LNAS PRDGM INS V2.3 SK EN LN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·December 10, 2010

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 24, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 24, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 24, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 30, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 24, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·August 11, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·August 11, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 24, 2021

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·November 13, 2014

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025