3 results
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21ms
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Sources: EU EUDAMED, US FDA
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1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 15, 2016
Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 14, 2016
Philips Brilliance 64 computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018