4 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
FDA Enforcement
Class I
·Terminated·Draeger Medical Systems, Inc.·April 16, 2014
Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
FDA Enforcement
Class I
·Terminated·Draeger Medical Systems, Inc.·April 9, 2014
Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications.
FDA Enforcement
Class I
·Terminated·Draeger Medical Systems, Inc.·June 13, 2018
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications
FDA Enforcement
Class I
·Terminated·Draeger Medical Systems, Inc.·June 13, 2018