8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SENTINEL LIPASE LIQUID MODEL 17.401B
FDA 510(k)
FDA Class 1
·Clinical Chemistry
C-STEM
FDA UDI
DEPUY (IRELAND)·10603295235330·C-STEM CANAL REAMER 12MM
Intelli-Ox
FDA 510(k)
FDA Class 1
·Anesthesiology
POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
CARE ASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·May 28, 2014
HEARTWARE® VENTRICULAR ASSIST SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·February 14, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 11, 2011
Pressure Monitoring Tray, C-PMSY, G02854
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 10, 2020