510(k) Report

FDA applicant

Carter Products

Cranbury, NJ20 decisions1988–19960 recalls

FDA records 20 decisions for Carter Products (Cranbury, NJ) from 1988 to 1996: 20 510(k) clearances. Most are in product codes HIS (Condom) and MOL (Condom, Synthetic). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Carter Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Carter Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Carter”

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