5 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
FDA 510(k)
FDA Class 2
·Microbiology
INVOcell
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PneumoLiner
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
T:SLIM X2 WITH INTEROPERABLE TECHNOLOGY: DEN180058
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·April 18, 2022
T:SLIM X2 WITH INTEROPERABLE TECHNOLOGY: DEN180058
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·April 29, 2022