12 results
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20ms
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Sources: EU EUDAMED, US FDA
MODIFIED VISIO-SEAL
FDA 510(k)
FDA Class 2
·Dental
GC Initial™
FDA UDI
Gc America Inc.·J0228730691·GC Initial™ AL Enamel E-59, 20g
MODIFICATION TO AVEA VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SHELL KRATON THERMO-PLASTIC RUBBER COMP.
FDA 510(k)
FDA Class 1
·Anesthesiology
VIASYS
FDA Adverse Event
Malfunction
·CAREFUSION 207, INC·Product code CBK·October 26, 2009
REPLACEMENT HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 13, 2014
PUMP MMT-722RNAB PRDGM INS BL EN RC
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·October 15, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·December 13, 2012
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC·Product code CBK·October 27, 2009
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC.·Product code CBK·October 27, 2009
Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013