510(k) K122953 ยท LZG Pump, Infusion, Insulin
OMNIPOD INSULIN MANAGMENT SYSTEM
| Applicant | Insulet Corporation, Bedford MA, US |
| Decision | Substantially Equivalent, Dec 7, 2012 |
| Received | Sep 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2015 | Insulet Corporation OmniPod, Insulin Management System (US)
Catalog Number: PODZXP420
Product Usage:
The OmnniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for Terminated |
LZG | None listed |
| Dec 15, 2015 | Insulet Corporation OmniPod, Insulin Management System (OUS)
Catalog Number: 14810
Product Usage:
The OmnniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for th Terminated |
LZG | None listed |
| Sep 10, 2015 | Elcam Medical, Inc. Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quan Terminated |
LZG | None listed |
| Sep 10, 2015 | Elcam Medical, Inc. Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., US Terminated |
LZG | None listed |
| Sep 4, 2015 | Insulet Corporation OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management Terminated |
LZG | None listed |
| Sep 4, 2015 | Insulet Corporation OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of Terminated |
LZG | None listed |
| Nov 5, 2013 | Insulet Corporation OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit)
Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Ins Terminated |
LZG | None listed |
| Nov 5, 2013 | Insulet Corporation OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490)
Product Usage:
The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by heal Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.