3 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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AcoSound. Model Number: LW12-BTE-M
FDA Enforcement
Class III
·Ongoing·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.·June 25, 2025
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDIOVASC ADULT, Pack Number DYNJ905472B; f) AV FISTULA, Pack Number DYNJ908096A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
FDA Enforcement
Class II
·Ongoing·Btt Health Gmbh·September 25, 2024