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 its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Trimedyne with 58 510(k) clearances. The most recent is a 510(k) clearance dated Dec 21, 2005: VAPORMAX II.
| Dec 21, 2005 | VAPORMAX IIK053457 · GEX | 510(k) clearances |
| Mar 14, 2005 | VAPORMAXK050412 · GEX | 510(k) clearances |
| Nov 17, 2004 | OMNIPULSE MINI, MODEL 2120K043012 · GEX | 510(k) clearances |
| Sep 8, 2004 | TRIMEDYNE HOLMIUM LASER SYSTEMSK041660 · GEX | 510(k) clearances |
| Nov 7, 2002 | TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHK022655 · GEX | 510(k) clearances |
| Sep 23, 2002 | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-AK013974 · GEX | 510(k) clearances |
| Dec 20, 2000 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-AK002308 · GEX | 510(k) clearances |
| Nov 2, 2000 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-AK001676 · 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
