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 14, 2026, FDA's public records list Ipax with 18 510(k) clearances. The most recent is a 510(k) clearance dated May 4, 2021: ProntoPump Sterile Tube Set.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 4, 2021 | ProntoPump Sterile Tube SetK200893 · LHI | 510(k) clearances |
| Dec 17, 1997 | BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)K971242 · MML | 510(k) clearances |
| Jun 20, 1997 | BLINK EXTERNAL EYELID WEIGHTK971245 · MML | 510(k) clearances |
| Feb 12, 1992 | SUREBREATH DOME, E-Z BREATHERK915158 · GAD | 510(k) clearances |
| Dec 27, 1991 | PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBEK915118 · HQC | 510(k) clearances |
| Oct 25, 1991 | KPE 220 TS, NONSTERILEK914221 · HQE | 510(k) clearances |
| Oct 25, 1991 | KPE 230 AMK914172 · HQC | 510(k) clearances |
| Oct 7, 1988 | SUREBREATH DOMEK884076 · GAD | 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
