8 results
·
51ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Cables and Sensors
FDA UDI
XINMED SDN. BHD.·09551028900014·Disposable ECG Lead Wires/MQ style/5-lead/grabb...
Cables and Sensors
FDA UDI
XINMED SDN. BHD.·09551028900069·Reusable SpO2 sensor/Nellcor-OXIMAX/Finger clip...
SAGE
FDA UDI
XINMED SDN. BHD.·09551028900007·Disposable ECG Lead Wires/HP style/5-lead/Grabb...
XINMED SDN. BHD.
FDA registration
XINMED SDN. BHD.·4 products·🇲🇾 Malaysia
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·September 7, 2016
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
FDA Enforcement
Class I
·Terminated·Teleflex Medical·February 18, 2015
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
FDA Recall
Terminated
·Teleflex Medical·Product code BYD·December 3, 2015
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
FDA Recall
Terminated
·Teleflex Medical·Product code BYD·January 12, 2015