2 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.
FDA Enforcement
Class I
·Terminated·Insulet Corporation·November 23, 2022
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
FDA Enforcement
Class I
·Terminated·Arrow International Inc·July 4, 2012