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 13, 2026, FDA's public records list Ultimed, Inc. with 10 510(k) clearances. The most recent is a 510(k) clearance dated Dec 16, 2021: UltiCare Disposable Pen Needles.
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.
| Date | Record | Source |
|---|---|---|
| Dec 16, 2021 | UltiCare Disposable Pen NeedlesK213407 · FMI | 510(k) clearances |
| Feb 9, 2015 | ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLEK140949 · MEG | 510(k) clearances |
| Jun 3, 2010 | ULTICARE DISPOSABLE PEN NEEDLESK100812 · FMI | 510(k) clearances |
| Jun 25, 2008 | ULTIMED ULTICARE SAFETY SYRINGEK080600 · MEG | 510(k) clearances |
| Jun 3, 2008 | ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINERK081449 · MMK | 510(k) clearances |
| Nov 29, 2006 | ULTICARE DISPOSABLE SYRINGES AND NEEDLESK062702 · FMF | 510(k) clearances |
| May 11, 2005 | ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2K050464 · FMI | 510(k) clearances |
| Dec 30, 2003 | ULTICARE DISPOSABLE SYRINGE 3 ML/CCK033794 · FMF | 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
