8 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Scenium VE20 Software
FDA 510(k)
FDA Class 2
·Radiology
DX-D 100
FDA 510(k)
FDA Class 2
·Radiology
MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·June 17, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2011
PI CVC KIT: 3-L 7 FR X 20 CM AGB
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code FOZ·August 7, 2014
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025