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Regulation 868.1890
5510(k)s in 12 months (56 all time)
3recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in NDC
| Company | 510(k)s | Recalls |
|---|---|---|
| Monarch Medical Technologies | 6 | 2 |
| Roche Diabetes Care, Inc. | 1 | 6 |
| Medtronic Minimed | 2 | 4 |
| Voluntis Sa. | 5 | 1 |
| Companion Medical, Inc. | 4 | 1 |
| Glytec, LLC | 4 | 0 |
| Glooko, Inc. | 2 | 0 |
| Roche Diagnostics Corp. | 2 | 0 |
| Sanofi | 2 | 0 |
| Welldoc, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | Medtronic MiniMed, Inc. Generic Name: MiniMed Go App
Generic Name: MiniMed Go App
Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android)
Software Version: Software version 1.2.1
Product Description: The MiniMed Go app for Open, Classified |
NDC | K253512 |
| Jul 23, 2026 | Medtronic MiniMed, Inc. MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) Open, Classified |
NDC | K253512 |
| Dec 18, 2025 | Medtronic MiniMed, Inc. InPen App, Model/CFN Number: MMT-8061 (Android Users) Open, Classified |
NDC | K242775 |
| Sep 2, 2025 | Medtronic MiniMed, Inc. InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) Open, Classified |
NDC | K242775 |
| Dec 20, 2022 | Companion Medical, Inc. InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA. Open, Classified |
NDC | K201337 |
| Oct 1, 2019 | Monarch Medical Technologies EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) Terminated |
NDC | None listed |
| May 3, 2019 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App Terminated |
NDC | K150910 |
| May 3, 2019 | Monarch Medical Technologies Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10. Open, Classified |
NDC | K132547 |
| Oct 8, 2018 | Voluntis Insulia Diabetes Management Companion Terminated |
NDC | K170669 K172177 |
| Jun 8, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 Terminated |
NDC | K150910 |
| Jun 8, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017
The Accu-Chek Connect Diabetes Mana Terminated |
NDC | K150910 |
| Mar 14, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
Product Usage:
This is a digital product available for download direct to customers from the Apple App St Terminated |
NDC | K150910 |
| Jan 26, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App Terminated |
NDC | K150910 |
| Nov 16, 2016 | Roche Diabetes Care, Inc. Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016 Terminated |
NDC | K150910 |
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