2 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
FDA Enforcement
Class II
·Completed·Materialise N.V.·August 9, 2023
Spiral Gold Hollow Fiber Oxygenator with Duraflow Treatment, a hollow fiber membrane oxygenator.
FDA Recall
Completed
·Jostra-Bentley Corporation·November 1, 2002