10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category)
FDA 510(k)
FDA Class 2
·Cardiovascular
ARSTASIS ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Other
·ARSTASIS INC.·Product code DYB·November 15, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Malfunction
·ARSTASIS, INC.·Product code DYB·November 19, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Other
·ARSTASIS, INC.·Product code DYB·November 22, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Injury
·ARSTASIS, INC.·Product code DYB·November 1, 2010
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·June 3, 2013
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 28, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·August 26, 2008