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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Domain Surgical with 6 510(k) clearances and 1 device recall. The most recent is a device recall dated Oct 24, 2016: FMsealer Open Shears. Model FM3001.
| Oct 24, 2016 | FMsealer Open Shears. Model FM3001Class II · Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during | Device recalls |
| Jan 2, 2015 | Laparoscopic FMsealerK142229 · GEI | 510(k) clearances |
| Jul 30, 2014 | OPEN FMSEALERK141484 · GEI | 510(k) clearances |
| May 23, 2014 | FMWAND HANDPIECE SEK140384 · GEI | 510(k) clearances |
| Jan 3, 2014 | FMWAND FERROMAGNETIC SURGICAL SYSTEMK130606 · HGI | 510(k) clearances |
| Oct 18, 2012 | DOMAIN SURGICAL SYSTEMK121881 · HGI | 510(k) clearances |
| Jul 18, 2011 | DOMAIN SURGICAL SYSTEMK110439 · GEI | 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
