2 results
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15ms
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Sources: EU EUDAMED, US FDA
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·November 19, 2025
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·February 3, 2021