Company ยท US
Bardy Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2023. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 2023 | K233110 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| Feb 5, 2021 | K210036 | Carnation Ambulatory Monitor (CAM) Bardy Diagnostics, Inc. | DSH |
| May 1, 2020 | K200870 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| Oct 17, 2019 | K192556 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| Aug 30, 2019 | K191471 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| May 16, 2019 | K191000 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| Dec 22, 2014 | K143067 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||