10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ESPRIT VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981072·anteriors; shade A3; mould IM4
TRAP-BLOOD VESSEL STABILIZATION DEVICE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SHILEY FEMORAL ARTERIAL CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·August 5, 2005
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC·Product code OTP·February 27, 2013
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·February 8, 2011
L-CLIP PERM BAYONET 7 MM
FDA Adverse Event
Malfunction
·PETER LAZIC GMBH·Product code HCI·December 18, 2013
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025