2 results
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8ms
·
Sources: EU EUDAMED, US FDA
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·August 20, 2025
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·February 10, 2021