510(k) Report

FDA applicant

Tutogen Medical U.S., Inc.

Alachua, FL2 decisions2000–20080 recalls

FDA records 2 decisions for Tutogen Medical U.S., Inc. (Alachua, FL) from 2000 to 2008: 2 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and NPL (Barrier, Animal Source, Intraoral). Its devices cite 1 predicate, 0 of them its own earlier devices. No 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 Tutogen Medical U.S., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tutogen Medical U.S., Inc. 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?

  • FTMMesh, Surgical1decision
  • NPLBarrier, Animal Source, Intraoral1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K073097Tutodent Dental MembraneTutogen Medical U.S., Inc. · 20084cite it

What has FDA decided for it lately?

  • K073097Tutodent Dental MembraneTutogen Medical U.S., Inc. · 2008
  • K991296TutopatchTutogen Medical U.S., Inc. · 2000

All 2 as Tutogen Medical U.S., Inc. →