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 Bio-Plexus with 6 510(k) clearances. The most recent is a 510(k) clearance dated Jan 8, 2001: PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION.
| Jan 8, 2001 | PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTIONK003827 · FMI | 510(k) clearances |
| Sep 9, 1999 | PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750K992091 · FMI | 510(k) clearances |
| Jun 6, 1997 | BIO-PLEXUS DROP-IT NEEDLE HOLDERK963748 · FMI | 510(k) clearances |
| Aug 28, 1996 | BIO-PLEXUS NEEDLE DISPOSAL CONTAINERK960933 · FMI | 510(k) clearances |
| Jun 27, 1996 | PUNCTUR-GUARD WINGED SETK961251 · FMI | 510(k) clearances |
| Sep 21, 1990 | PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLEK895024 · FMI | 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