3 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025