Company ยท US
Guard Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2025. 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 |
|---|---|---|
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2025 | K251156 | NPseal Guard Medical, Inc. | OKO |
| Apr 8, 2025 | K250708 | NPseal Guard Medical, Inc. | OKO |
| Aug 15, 2024 | K241522 | NPseal (20 and 25) Guard Medical, Inc. | OKO |
| Feb 29, 2024 | K240244 | NPseal (Small, Medium, Large) Guard Medical, Inc. | OKO |
| Feb 10, 2022 | K212971 | NPseal Guard Medical, Inc. | OKO |
| May 14, 2021 | K211130 | NPseal Guard Medical, Inc. | OKO |
| May 26, 2020 | K200305 | NPseal Guard Medical, Inc. | OKO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||