5 results
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52ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.
FDA Recall
Open, Classified
·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.
FDA Recall
Open, Classified
·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
FDA Recall
Open, Classified
·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
FDA Recall
Open, Classified
·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.
FDA Recall
Open, Classified
·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020