Company ยท US
Companion Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2020. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2020 | K201337 | InPen System Companion Medical, Inc. | NDC |
| Feb 18, 2020 | K190487 | InPen Dose Calculator Companion Medical, Inc. | NDC |
| Feb 10, 2020 | K192841 | InPen System Companion Medical, Inc. | NDC |
| Jul 6, 2018 | K181327 | InPen Dose Calculator Companion Medical, Inc. | NDC |
| Jul 26, 2016 | K160629 | InPen Companion Medical, Inc. | FMF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |