2 results
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15ms
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Sources: EU EUDAMED, US FDA
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
FDA Enforcement
Class I
·Terminated·LivaNova USA Inc·January 1, 2020
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.
FDA Enforcement
Class I
·Terminated·BERLIN HEART GMBH·May 31, 2023