Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Smith & NephewLabelled by claude-sonnet-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 Opus Medical with 13 510(k) clearances. The most recent is a 510(k) clearance dated Dec 14, 2004: OPUS MINIMAGNUM ANCHOR WITH INSERTER.
| Dec 14, 2004 | OPUS MINIMAGNUM ANCHOR WITH INSERTERK042584 · HWC | 510(k) clearances |
| Nov 12, 2004 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLEK042914 · MBI | 510(k) clearances |
| Oct 19, 2004 | OPUS SPEEDSTITCH SUTURE DEVICEK042031 · GAT | 510(k) clearances |
| Jun 25, 2004 | OPUS MAGNUM ANCHOR WITH INSERTERK041440 · MBI | 510(k) clearances |
| Dec 30, 2003 | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070K033317 · OCW | 510(k) clearances |
| Jul 28, 2003 | REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500K030170 · OCW | 510(k) clearances |
| Jun 12, 2003 | OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500K031083 · HTY | 510(k) clearances |
| Apr 23, 2003 | F1 DIODE LASER SYSTEMK030235 · GEX | 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
