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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 8 of 8 Results
510(K) Number: K122953
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OmniPod®, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod®... 1 12/15/2015 Insulet Corporation
OmniPod®, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod® I... 1 12/15/2015 Insulet Corporation
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitor... 2 09/10/2015 Elcam Medical, Inc.
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid ... 2 09/10/2015 Elcam Medical, Inc.
OmniPod® Insulin Management System. Only the OmniPod® device is affected. Catalog Number(s): POD-ZXP... 1 09/04/2015 Insulet Corporation
OmniPod® Insulin Management System. Only the OmniPod® device is affected. Catalog Number(s): 14810 ... 1 09/04/2015 Insulet Corporation
OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) P... 2 11/05/2013 Insulet Corporation
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Produc... 2 11/05/2013 Insulet Corporation
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