Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Biomedix, Inc. with 11 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Aug 29, 2014: SELEC-3 I.V.ADMINISTRATION SET.
| Aug 29, 2014 | SELEC-3 I.V.ADMINISTRATION SETK142097 · FPA | 510(k) clearances |
| Aug 14, 2014 | Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched unClass II · Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units ori | Device recalls |
| Aug 29, 2012 | PADNET 2.0K122281 · JOM | 510(k) clearances |
| Nov 21, 2007 | PADNET+K073146 · JOM | 510(k) clearances |
| Aug 9, 2005 | Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEMK050182 · CGA | 510(k) clearances |
| Oct 12, 2004 | BIOMEDIX PADNET LABK042616 · JOM | 510(k) clearances |
| May 21, 2004 | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEMK033627 · CGA | 510(k) clearances |
| Dec 29, 1997 | FLOSTAT VASCULAR REPORT GENERATOR (VRG)K973857 · JAF | 510(k) clearances |
| Dec 23, 1997 | FLOSTAT VASCULAR LABK973644 · JAF | 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
