510(k) Report

FDA applicant

Aragona Medical, Inc.

Woodcliff Lake, NJ2 decisions1987–19870 recalls

FDA records 2 decisions for Aragona Medical, Inc. (Woodcliff Lake, NJ) in 1987: 2 510(k) clearances. All are in product code FMT (Warmer, Infant Radiant). 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Aragona Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aragona Medical, 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?

  • FMTWarmer, Infant Radiant2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K871178MTC XI ULAragona Medical, Inc. · 19871cites it

What has FDA decided for it lately?

  • K871177NTH 101 ULAragona Medical, Inc. · 1987
  • K871178MTC XI ULAragona Medical, Inc. · 1987

All 2 as Aragona Medical, Inc. →

Other applicant names beginning “Aragona”

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

Aragona AB Co. 1