510(k) Report

FDA applicant

Int'L Corp.

Scottsdale, AZ4 decisions1980–19841 recall

FDA records 4 decisions for Int'L Corp. (Scottsdale, AZ) from 1980 to 1984: 4 510(k) clearances. Most are in product codes EMA (Cement, Dental) and FOS (Catheter, Umbilical Artery). 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, dental panel, where it files most

How often FDA has decided Int'L Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Int'L Corp. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Int'L Corp. 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?

  • EMACement, Dental2decisions
  • FOSCatheter, Umbilical Artery1decision
  • KDDKit, Surgical Instrument, Disposable1decision

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.

  • K842994Ema Freegenol Dental CementInt'L Corp. · 19842cite it

What has FDA decided for it lately?

  • K842995Ema Liv Cenera Dental CementInt'L Corp. · 1984
  • K842994Ema Freegenol Dental CementInt'L Corp. · 1984
  • K821814Hemo-Nate L-P KitInt'L Corp. · 19821 recall
  • K802414Umbili-Cath CatheterInt'L Corp. · 1980

All 4 as Int'L Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K821814Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile…Oct 16, 2015Class II