FDA applicant
Carter Products
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
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.
Planning a device like Carter Products’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Carter”
FDA records each applicant name separately; these may or may not be the same firm.