8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTI PURPOSE SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
E-SARANG 86, DM78, DM55
FDA 510(k)
FDA Class 2
·Dental
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
FDA 510(k)
FDA Class 2
·Radiology
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 27, 2014
OVATIO
FDA Adverse Event
Malfunction
·SORIN CRM·Product code MRM·October 26, 2012
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 14, 2010
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