Company ยท CA
Profound Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2024. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 9, 2024 | K240296 | Tulsa Pro System (Pad-105) Profound Medical, Inc., CA | PLP |
| Sep 20, 2023 | K230692 | TULSA-PRO System Profound Medical, Inc., CA | PLP |
| Sep 6, 2022 | K211858 | TULSA-PRO System Profound Medical, Inc., CA | PLP |
| Sep 16, 2020 | K202286 | Tulsa-Pro System Profound Medical, Inc., CA | PLP |
| Aug 15, 2019 | K191200 | TULSA-PRO System Profound Medical, Inc., CA | PLP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||