3 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
FDA Enforcement
Class II
·Ongoing·FX SHOULDER·February 7, 2024
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 18, 2025
OEC 3D
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 18, 2025