Medical device makerLabelled 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 14, 2026, FDA's public records list Roseburg SA with 24 510(k) clearances. The most recent is a 510(k) clearance dated Sep 1, 1994: STAPLE, FIXATION BONE; SCREW FIXATION BONE.
| Sep 1, 1994 | STAPLE, FIXATION BONE; SCREW FIXATION BONEK931155 · HWC | 510(k) clearances |
| Mar 9, 1989 | CALIUS-ISABEL CANOVAS SUNGLASSESK890081 · HQY | 510(k) clearances |
| Jan 24, 1989 | ASSENAT-BLESCHET SUNGLASSESK885275 · HQY | 510(k) clearances |
| Aug 26, 1988 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESK882392 · KGO | 510(k) clearances |
| Dec 7, 1987 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYK872715 · JDN | 510(k) clearances |
| Nov 17, 1987 | POIRIER KID-ROLLER MANUAL WHEELCHAIRK874317 · IOR | 510(k) clearances |
| Jul 21, 1987 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARYK872714 · GBI | 510(k) clearances |
| May 29, 1987 | SPECTACLE FRAME - DANIELLEK871688 · HQZ | 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
