5 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Enforcement
Class II
·Ongoing·Barco N.V.·July 2, 2025
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One North America, Inc.·November 5, 2025
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
FDA Enforcement
Class I
·Ongoing·FHC, Inc.·November 20, 2024
Bodor's I series laser cutting machine.
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·July 30, 2025
Bodor P and C series laser cutting machines
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·January 29, 2025