Company
Tecfen Medical
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HNN | Knife, Ophthalmic | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2025 | Tecfen Medical Brand Name: Tecfen Medical
Product Name: 3.2mm Slit Knife, Angled
Model/Catalog Number: QKN3261
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be st Open, Classified |
HNN | None listed |
| Jun 11, 2025 | Tecfen Medical Brand Name: Tecfen Medical
Product Name: 2.0mm Crescent Knife Angled Bevel Up
Model/Catalog Number: QKN1010
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that Open, Classified |
HNN | None listed |
| Jun 11, 2025 | Tecfen Medical Brand Name: Tecfen Medical
Product Name: 20G (1.2mm) MVR Sideport Knife Straight
Model/Catalog Number: QKN2312
Software Version: No software
Product Description: This is an ophthalmic knife (manual( t Open, Classified |
HNN | None listed |
| Jun 11, 2025 | Tecfen Medical Brand Name: Tecfen Medical
Product Name: 2.8mm Slit Knife, Angled
Model/Catalog Number: QKN2808
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be st Open, Classified |
HNN | None listed |
| Jun 11, 2025 | Tecfen Medical Brand Name: Tecfen Medical
Product Name: 2.4mm Slit Knife, Angled
Model/Catalog Number: QKN2461
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be st Open, Classified |
HNN | None listed |
| Jun 11, 2025 | Tecfen Medical Brand Name: Tecfen Medical
Product Name: 2.2mm Slit Knife, Angled
Model/Catalog Number: QKN2261
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be st Open, Classified |
HNN | None listed |
| Jun 11, 2025 | Tecfen Medical Brand Name: Tecfen Medical
Product Name: 15 degree Stab Knife
Model/Catalog Number: QKN1501
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be steril Open, Classified |
HNN | None listed |