7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
FDA 510(k)
FDA Class 2
·Microbiology
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
STELLAR 150
FDA 510(k)
FDA Class 2
·Anesthesiology
PATROL PUMP
FDA Adverse Event
Malfunction
·ABBOTT NUTRITION·Product code LZH·October 7, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2013
EON MINI 16-CHANNEL RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 21, 2011
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016