US device clearances
31 510(k) clearances and PMA approvals since 2015
- Alexis Lighted Wound Protector-Retractor, Flexible, Extra Small (Cl312);Alexis … K260982 · 24 Apr 2026
- Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (Cl402); Alexis® Light… K253531 · 23 Feb 2026
- Voyant® Open Fusion Device (Eb240/Open Fusion) K252740 · 4 Nov 2025
- Voyant® Electrosurgical Generator (Ea030/Electrosurgical Generator) K252412 · 31 Oct 2025
- Kii Structural Balloon Access System K252442 · 31 Oct 2025
Source: FDA 510(k) and PMA databases, 510(k) clearances, and PMA approvals or changes, since 2015; newest shown. Retrieved 13 Nov 2026.