Medical device makerLabelled 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 Baldur Systems with 6 510(k) clearances. The most recent is a 510(k) clearance dated Aug 11, 1998: OPERATING ROOM TOWELS.
| Aug 11, 1998 | OPERATING ROOM TOWELSK981823 · KKX | 510(k) clearances |
| Feb 10, 1998 | BALDUR NON-STERILE COTTON SPONGESK974347 · EFQ | 510(k) clearances |
| Sep 11, 1989 | PATIENT EXAMINATION GLOVES (LATEX)K892684 · LYY | 510(k) clearances |
| May 25, 1989 | LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)K891728 · LYY | 510(k) clearances |
| May 12, 1989 | LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD)K891727 · LYY | 510(k) clearances |
| May 12, 1989 | VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)K891726 · LYZ | 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
