9 results
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7ms
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Sources: EU EUDAMED, US FDA
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
FDA Enforcement
Class II
·Ongoing·Aesculap AG·October 8, 2025
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
FDA Enforcement
Class II
·Ongoing·Aesculap AG·October 8, 2025
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·September 17, 2025
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024