Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwitzerlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Medartis with 47 510(k) clearances and 5 device recalls. The most recent is a 510(k) clearance dated Jun 5, 2026: APTUS Clavicle System 2.8.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 5, 2026 | APTUS Clavicle System 2.8K260761 · HRS | 510(k) clearances |
| Apr 17, 2026 | TITAN Nail; APTUS K-Wire SystemK260934 · HWC | 510(k) clearances |
| Mar 16, 2026 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5K253916 · HRS | 510(k) clearances |
| Mar 7, 2025 | APTUS Hand System; APTUS Elbow Dorsal OlecranonK243610 · HRS | 510(k) clearances |
| Jun 20, 2024 | APTUS Elbow Dorsal Olecranon PlatesK240613 · HRS | 510(k) clearances |
| Apr 19, 2024 | APTUS Foot System 2.8-3.5K232105 · HRS | 510(k) clearances |
| Apr 12, 2024 | APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.Class II · Screw is 16mm long instead of 22mm long. | Device recalls |
| Mar 21, 2024 | APTUS Hand Scaphoid PlatesK234062 · HRS | 510(k) clearances |
| Nov 3, 2023 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionK232251 · HWC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
