5 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Recall
Completed
·Materialise USA LLC·Product code HWT·July 13, 2022
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Enforcement
Class II
·Completed·Materialise USA LLC·August 31, 2022
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
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 Recall
Completed
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·June 19, 2023
Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.
FDA Recall
Completed
·RHONDIUM LIMITED·Product code EBF·January 31, 2019