Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of ÖssurLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Össur Americas with 14 device recalls and 2 510(k) clearances. The most recent is a 510(k) clearance dated May 2, 2013: DVTCARE CA5.
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.
| May 2, 2013 | DVTCARE CA5K130174 · JOW | 510(k) clearances |
| Oct 15, 2012 | The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG Class II · OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg | Device recalls |
| Feb 12, 2012 | The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the Class II · OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics. | Device recalls |
| May 25, 2007 | RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100DK071173 · HAX | 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
