4 results
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11ms
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Sources: EU EUDAMED, US FDA
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
FDA Enforcement
Class II
·Terminated·Owen Mumford USA, Inc.·July 22, 2015
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
FDA Enforcement
Class III
·Terminated·Datascope Corporation·June 13, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
FDA Enforcement
Class III
·Terminated·Datascope Corporation·June 13, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
FDA Enforcement
Class III
·Terminated·Datascope Corporation·June 13, 2018