Johnson & Johnson - FDA 510(k) Cleared Devices

Johnson & Johnson, is a global healthcare company with a manufacturing facility in Raynham, Massachusetts. The company develops medicines, therapies, and medical devices across multiple therapeutic areas.

The company has received 9 FDA 510(k) clearances from 9 total submissions, with no denied submissions on record. Orthopedic devices represent the dominant focus, accounting for 78% of regulatory activity. Clearances span from 2011 to 2012, reflecting a historical record of FDA regulatory engagement in spinal and orthopedic surgery systems.

Notable cleared devices include spinal fixation and access systems designed for complex surgical procedures. The company's portfolio demonstrates expertise in orthopedic and neurosurgical instrumentation.

This company profile is maintained as a historical regulatory record. For detailed information on specific device names, product codes, and clearance dates, review the complete 510(k) submission history.