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 Gish Biomedical with 75 510(k) clearances. The most recent is a 510(k) clearance dated Sep 18, 2009: MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT.
| Sep 18, 2009 | MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LTK090449 · DTZ | 510(k) clearances |
| Sep 18, 2009 | MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LTK090450 · DTZ | 510(k) clearances |
| Aug 4, 2009 | MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730K091062 · DTN | 510(k) clearances |
| Jul 30, 2009 | MEDOS HILITE RESERVOIR, MODEL: 4030K083131 · DTN | 510(k) clearances |
| May 15, 2009 | MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LTK082403 · DTZ | 510(k) clearances |
| Feb 4, 2009 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATINGK081947 · DTN | 510(k) clearances |
| Feb 4, 2009 | GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATINGK082082 · DTN | 510(k) clearances |
| Feb 2, 2009 | VISION HOLLOW FIBER OXYGENATOR WITH HA COATINGK080708 · DTZ | 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
