2 results
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8ms
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Sources: EU EUDAMED, US FDA
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCM; 5) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAS; 6) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAT; 7) Cardiovascular Procedure Kit, Catalog Number SANOCAENSA; 8) Cardiovascular Procedure Kit, Catalog Number SCV29ANCCA; 9) Left Heart Kit, Catalog Number SAN73LHKCC; 10) Left Heart Kit, Catalog Number SAN73LHKC6
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·July 17, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021