Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IcelandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Össur and its 3 subsidiaries with 87 510(k) clearances and 44 device recalls. The most recent is a device recall dated Oct 24, 2013: Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Össur and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 24, 2013 | Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the cClass II · Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal | Device recalls |
| May 2, 2013 | DVTCARE CA5K130174 · JOW | 510(k) clearances |
| May 25, 2007 | RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100DK071173 · HAX | 510(k) clearances |
| Jul 6, 2004 | 3DKNEE POROUS COATED FEMORAL COMPONENTK032905 · MBH | 510(k) clearances |
| Jul 12, 2002 | 3D KNEEK020114 · JWH | 510(k) clearances |
| Jun 4, 2002 | UNICONDYLAR KNEEK020741 · HRY | 510(k) clearances |
| Feb 14, 2002 | MODIFICATION TO PASS SPINAL SYSTEMK020236 · KWP | 510(k) clearances |
| Feb 11, 2002 | KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UPK020170 · LPH | 510(k) clearances |
| Jan 17, 2002 | CEMENTED CALCAR HIP SYSTEMK013490 · LPH | 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
