FDA applicant

Prime Horizon, Inc.

East Hanover, NJ1 decision1989–19890 recalls

FDA records 1 decision for Prime Horizon, Inc. (East Hanover, NJ) in 1989: 1 510(k) clearance. All are in product code LYY (Latex Patient Examination Glove). 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 Prime Horizon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prime Horizon, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prime Horizon, 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 “Prime”

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

Prime Dental Manufacturing, Inc. 9 Prime Herbs Corporation 2 Prime Pacific Health Innovations Corporation 2 Prime Medical Products, Inc. 2 Prime Ideas, Inc. 1 Prime Merit Intl. Corp. 1 Prime Engineering 1

Prime Horizon, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Prime”