Stock: NVST. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
217
De Novo: 1
PMA approvals
0
0 supplements
Recalled products
107
0 class I
Adverse event reports
1.5M
24 deaths reported
Envista has 107 recalled medical device products in 45 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Jan 10, 2025. In 2022 it had 1 recalled products.
217 510(k) clearances, 1 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Sep 8, 2026.
1,532,910 reports in total: 24 deaths, 1,517,733 injuries and 15,099 malfunctions were reported. 270,939 reports were received in 2025. A report alone does not show that the device caused the problem.
Last 15 years
| Year | 510(k) clearance | De Novo grant | PMA approval | PMA supplement |
|---|---|---|---|---|
| 2026 | 3 | 0 | 0 | 0 |
| 2025 | 5 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · NVST stock page
Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to NVST with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.
| 4 |
| 0 |
| 0 |
| 0 |
| 2022 | 3 | 0 | 0 | 0 |
| 2021 | 5 | 0 | 0 | 0 |
| 2020 | 5 | 0 | 0 | 0 |
| 2019 | 3 | 0 | 0 | 0 |
| 2018 | 7 | 0 | 0 | 0 |
| 2017 | 11 | 0 | 0 | 0 |
| 2016 | 9 | 0 | 0 | 0 |
| 2015 | 2 | 0 | 0 | 0 |
| 2014 | 5 | 0 | 0 | 0 |
| 2013 | 6 | 0 | 0 | 0 |
| 2012 | 1 | 0 | 0 | 0 |
| 2011 | 2 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 0 | 0 | 188,222 | - |
| 2025 | 1 | 0 | 270,939 | - |
| 2024 | 0 | 0 | 248,947 | - |
| 2023 | 0 | 0 | 232,498 | 1 |
| 2022 | 1 | 0 | 215,330 | 5 |
| 2021 | 6 | 0 | 189,255 | 4 |
| 2020 | 4 | 0 | 121,080 | 12 |
| 2019 | 34 | 0 | 61,992 | 1 |
| 2018 | 2 | 0 | 75 | - |
| 2017 | 1 | 0 | 98 | - |
| 2016 | 5 | 0 | 81 | - |
| 2015 | 29 | 0 | 49 | - |
| 2014 | 2 | 0 | 54 | - |
| 2013 | 5 | 0 | 80 | - |
| 2012 | 2 | 0 | 69 | - |