6 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Completed
×
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
FDA Recall
Completed
·EYE COMFORT CARE LLC·Product code IRT·February 8, 2024
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
FDA Enforcement
Class II
·Completed·EYE COMFORT CARE LLC·August 21, 2024
Destino Twist 14F (also branded as Guidestar 14F)
FDA Recall
Completed
·Oscor Inc.·Product code DYB·December 22, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
FDA Recall
Completed
·Biosense Webster, Inc.·Product code DYB·February 26, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
FDA Recall
Completed
·Biosense Webster, Inc.·Product code DYB·February 26, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
FDA Recall
Completed
·Biosense Webster, Inc.·Product code DYB·February 26, 2021