510(k) Report

FDA applicant

Horizon Medical Products, Inc.

Manchester, GA16 decisions1994–200311 recalls

FDA records 16 decisions for Horizon Medical Products, Inc. (Manchester, GA) from 1994 to 2003: 16 510(k) clearances. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and MSD (Catheter, Hemodialysis, Implanted). Its devices cite 13 predicates, 6 of them its own earlier devices. 11 recalls are 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 Horizon Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Horizon Medical Products, Inc. since 2007.

Recalls per year

1in 2022

2007: 12010: 72013: 12017: 12022: 1
2007high 7 (2010) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Horizon Medical Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Horizon”

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