Company ยท FI
Icare Finland OY
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2024. 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 |
|---|---|---|
| HKY | Tonometer, Manual | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 27, 2024 | K241447 | iCare ST500 (TA04) Icare Finland OY, FI | HKY |
| Oct 6, 2022 | K220852 | iCare IC200 Icare Finland OY, FI | HKY |
| Jan 25, 2022 | K211355 | iCare HOME2 Icare Finland OY, FI | HKY |
| May 7, 2020 | K200966 | Icare HOME Tonometer Icare Finland OY, FI | HKY |
| Jan 14, 2020 | K190316 | Icare ic200 Icare Finland OY, FI | HKY |
| Mar 21, 2017 | K163343 | Icare HOME tonometer Icare Finland OY, FI | HKY |
| Apr 19, 2016 | K153694 | Icare ic100 Icare Finland OY, FI | HKY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||