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 Olympus CorporationLabelled 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 13, 2026, FDA's public records list ACMI with 16 510(k) clearances. The most recent is a 510(k) clearance dated Aug 10, 2006: PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK.
| Date | Record | Source |
|---|---|---|
| Aug 10, 2006 | PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PKK061975 · GEI | 510(k) clearances |
| May 25, 2006 | ACMI DUR-HL LASER SYSTEMSK060752 · GEX | 510(k) clearances |
| Mar 31, 2006 | ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEMK060269 · FBN | 510(k) clearances |
| Sep 2, 2005 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224K051593 · KNY | 510(k) clearances |
| Aug 16, 2005 | ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6ALK052044 · FGB | 510(k) clearances |
| Mar 3, 2005 | DUAL LUMEN CATHETERK043581 · EYB | 510(k) clearances |
| Nov 1, 2004 | INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEMK042069 · GCJ | 510(k) clearances |
| Sep 10, 2004 | ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565K042225 · FAJ | 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
