510(k) Report

FDA applicant

Biomatrix, Inc.

Ridgefield, NJ2 decisions2000–20000 recalls

FDA records 2 decisions for Biomatrix, Inc. (Ridgefield, NJ) in 2000: 2 510(k) clearances. Most are in product codes EMX (Balloon, Epistaxis) and MRC (Products, Contact Lens Care, Rigid Gas Permeable). Its devices cite 3 predicates, 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, ear, nose and throat panel, where it files most

How often FDA has decided Biomatrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biomatrix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomatrix, 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?

  • EMXBalloon, Epistaxis1decision
  • MRCProducts, Contact Lens Care, Rigid Gas Permeable1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K993362HylasineBiomatrix, Inc. · 20002cite it

What has FDA decided for it lately?

  • K993362HylasineBiomatrix, Inc. · 2000
  • K994170Hylashield CLBiomatrix, Inc. · 2000

All 2 as Biomatrix, Inc. →