8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
OSTOMY APPLIANCE BELT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
MYRAY SKYVIEW
FDA 510(k)
FDA Class 2
·Dental
TSP Crosser Transseptal Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
HOLDING SLEEVE-LONG FOR MATRIX
FDA Adverse Event
Malfunction
·GRENCHEN SYNTHES PRODUKTIONS GMBH·Product code LXH·December 2, 2020
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 30, 2014
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·October 10, 2012
C-ARM
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 29, 2010
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026