FDA applicant
Johnson & Johnson
FDA records 12 decisions for Johnson & Johnson (Raynham, MA) from 2006 to 2012: 12 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 38 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Johnson & Johnson Company”, “Johnson & Johnson Co.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Johnson & Johnson’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Johnson & Johnson’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.