FDA applicant
Johnson & Johnson International
FDA records 10 decisions for Johnson & Johnson International (Arlington, TX) from 1989 to 1997: 10 510(k) clearances. Most are in product codes KWL (Prosthesis, Hip, Hemi-, Femoral, Metal) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Johnson & Johnson International’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Johnson & Johnson International since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Johnson & Johnson International’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 “Johnson”
FDA records each applicant name separately; these may or may not be the same firm.