8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS
FDA 510(k)
FDA Class 2
·Anesthesiology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909133952·REVELATION DIAMOND 862-014M - 5 PACK
LIFEJET VIDEO LINK
FDA 510(k)
FDA Class 2
·Radiology
REVERE 4.5 STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 14, 2014
NDEHP LS TWN 2CLVE
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·January 9, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 3, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015