510(k) Report

FDA applicant

Joseph B. Marogil

Grand Rapids, MI1 decision1985–19851 recall

FDA records 1 decision for Joseph B. Marogil (Grand Rapids, MI) in 1985: 1 510(k) clearance. All are in product code GAX (Tourniquet, Nonpneumatic). 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 Joseph B. Marogil’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Joseph B. Marogil since 2007.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Joseph B. Marogil 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?

  • GAXTourniquet, Nonpneumatic1decision

What has FDA decided for it lately?

  • K853472Finger TourniquetteJoseph B. Marogil · 19851 recall

The one decision as Joseph B. Marogil →

What has been recalled?

1 recall linked to its devices; the latest:

  • K853472Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet -…Dec 28, 2020Class II

Other applicant names beginning “Joseph”

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

Joseph M. Piocentile 1Joseph A. Resnick 1Joseph F. Daniel, C.R.N.A. 1Joseph A. Kott, M.D. 1