FDA applicant
Johnson & Johnson Medical, Inc.
FDA records 56 decisions for Johnson & Johnson Medical, Inc. (Arlington, TX) from 1990 to 2004: 56 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and HHW (Pessary, Vaginal). Its devices cite 31 predicates, 6 of them its own earlier devices. 6 recalls are linked to its devices.
FDA’s records also spell it “Johnson & Johnson Medical, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Johnson & Johnson Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Johnson & Johnson Medical, Inc. since 2007.
Recalls per year
5in 2011
Class I Class II/III not classified
Planning a device like Johnson & Johnson Medical, Inc.’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.