7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRAM NEGATIVE COMBO PANEL TYPE 3
FDA 510(k)
FDA Class 2
·Microbiology
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
FDA 510(k)
FDA Class 3
·Cardiovascular
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
FDA 510(k)
FDA Class 2
·Cardiovascular
MYOCARDIAL LEAD
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010
SYMBIQ SINGLE CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 28, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012