5 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
FDA Enforcement
Class II
·Completed·Teleflex Medical·October 25, 2017
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