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Calculator, Drug Dose
FDA product code NDC · Class 2 · Anesthesiology
154
Registered devices
1,898
Adverse events
13
Recalls
55
510(k) clearances
Devices with this code
BioButton v2 — BIOINTELLISENSE, INC.LivingConnected Diabetes Rx — WELLDOC, INC.inpen™ — COMPANION MEDICAL, INC.Insulia — VOLUNTISt:slim X2 Insulin Pump with Basal-IQ — Tandem Diabetes Care, Inc.Welldoc Rx — WELLDOC, INC.Welldoc — WELLDOC, INC.InPen Smart Insulin System — COMPANION MEDICAL, INC.inpen™ — MEDTRONIC MINIMED, INC.t:slim X2 Insulin Pump with Basal-IQ — Tandem Diabetes Care, Inc.Healthfirst Cares — WELLDOC, INC.t:slim X2 Insulin Pump with Basal-IQ — Tandem Diabetes Care, Inc.inpen™ — MEDTRONIC MINIMED, INC.T1D1 — Comerge AGInsulia — VOLUNTISBluestar Rx — WELLDOC, INC.Insulia — VOLUNTISWelldoc Rx — WELLDOC, INC.Omnipod 5 Controller — Insulet Corporationinpen™ — MEDTRONIC MINIMED, INC.inpen™ — MEDTRONIC MINIMED, INC.Welldoc — WELLDOC, INC.LivingConnected Diabetes Rx — WELLDOC, INC.t:slim X2 Insulin Pump with Control-IQ — Tandem Diabetes Care, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-16 | Medtronic MiniMed, Inc. | For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the assoc |
| 2025-11-13 | Medtronic MiniMed, Inc. | When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to al |
| 2025-06-16 | Medtronic MiniMed, Inc. | Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose rem |
| 2022-11-08 | Companion Medical, Inc. | Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to us |
| 2019-10-01 | Monarch Medical Technologies | Product was distributed prior to approval or clearance from FDA. |
| 2019-05-03 | Roche Diabetes Care, Inc. | Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. |
| 2019-05-03 | Monarch Medical Technologies | Insulin dosing calculations were erroneously high. |
| 2018-10-08 | Voluntis | The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high- |
| 2017-06-08 | Roche Diabetes Care, Inc. | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a custo |
| 2017-06-08 | Roche Diabetes Care, Inc. | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting |
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