510(k) Report

FDA applicant

Horizons Intl. Corp.

Ponce, PR10 decisions2001–20080 recalls

FDA records 10 decisions for Horizons Intl. Corp. (Ponce, PR) from 2001 to 2008: 10 510(k) clearances. Most are in product codes FDI (Snare, Flexible) and KGE (Forceps, Biopsy, Electric). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Horizons Intl. Corp.’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 — Horizons Intl. Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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