10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
HEMOSIL D-DIMER HS 500, CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
Viola
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPEN SPINE ANGLED CLAMP
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 14, 2013
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 7, 2013
CONSULTA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 7, 2014
TS ADMIN SET-BBRAUN (990264.SPE)-1 BOX
FDA Adverse Event
Malfunction
·BIOCOMPATIBLES UK LTD·Product code NAW·February 24, 2022
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code NAW·July 23, 2021
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 25, 2021