3 results
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7ms
·
Sources: EU EUDAMED, US FDA
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
FDA Enforcement
Class II
·Terminated·Otto Bock Healthcare GmbH·November 11, 2015
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
FDA Enforcement
Class II
·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·August 14, 2024
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
FDA Enforcement
Class II
·Ongoing·MAQUET GMBH·September 3, 2025