3 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
FDA Enforcement
Class I
·Ongoing·Given Imaging Ltd.·July 16, 2025
Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.
FDA Enforcement
Class I
·Terminated·MEDTECH SAS·November 13, 2019
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
FDA Enforcement
Class I
·Ongoing·MEDTECH SAS·November 3, 2021