510(k) Report

FDA applicant

Shire Regenerative Medicine

San Diego2 decisions1997–20011 recall

FDA records 2 decisions for Shire Regenerative Medicine (San Diego) from 1997 to 2001: 2 original PMA approvals. All are in product code MGR (Dressing, Wound And Burn, Interactive). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Shire Regenerative Medicine’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shire Regenerative Medicine since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shire Regenerative Medicine by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MGRDressing, Wound And Burn, Interactive2decisions

What has FDA decided for it lately?

  • P000036DermagraftShire Regenerative Medicine · 20011 recall
  • P960007Transcyte Human Fibroblast-Derived Temporary Skin SubstituteShire Regenerative Medicine · 1997

All 2 as Shire Regenerative Medicine →

What has been recalled?

1 recall linked to its devices; the latest:

  • P000036Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..May 2, 2003

Other applicant names beginning “Shire”

FDA records each applicant name separately; these may or may not be the same firm.

Shire Biologics, Inc. 1