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 OlympusLabelled 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 Gyrus ENT with 28 510(k) clearances. The most recent is a 510(k) clearance dated Aug 20, 2004: RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYS….
| Aug 20, 2004 | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEMK040996 · NIX | 510(k) clearances |
| Mar 3, 2004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLEK034004 · ERL | 510(k) clearances |
| Feb 5, 2004 | HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEMK033089 · GEI | 510(k) clearances |
| Nov 24, 2003 | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESISK033554 · ETB | 510(k) clearances |
| May 2, 2003 | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACEK030343 · HAW | 510(k) clearances |
| Oct 24, 2002 | GYRUS ENT NERVE STIMULATORK021595 · ETN | 510(k) clearances |
| Aug 26, 2002 | GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)K021777 · GEI | 510(k) clearances |
| May 28, 2002 | GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420K020778 · 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
