Company ยท US
Welldoc, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2023. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2023 | K222888 | BlueStar CGM insulin dose calculator Welldoc, Inc. | QRX |
| Jul 28, 2023 | K230813 | BlueStar and BlueStar Rx Welldoc, Inc. | NDC |
| Sep 8, 2021 | K203434 | BlueStar Rx Welldoc, Inc. | NDC |
| Apr 7, 2020 | K193654 | BlueStar Rx Welldoc, Inc. | MRZ |
| Nov 4, 2019 | K190013 | WellDoc BlueStar Welldoc, Inc. | MRZ |
| Jan 12, 2017 | K162532 | WellDoc BlueStar, WellDoc BlueStar Rx Welldoc, Inc. | MRZ |
| Nov 22, 2016 | K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System Welldoc, Inc. | MRZ |
| Jul 8, 2014 | K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE Welldoc, Inc. | MRZ |
| Feb 24, 2012 | K120314 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM Welldoc, Inc. | MRZ |
| Oct 14, 2011 | K112370 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM Welldoc, Inc. | MRZ |
| Jul 15, 2010 | K100066 | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 Welldoc, Inc. | MRZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||