Sanofi is one of 21940 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Sanofi - FDA 510(k) Cleared Devices
Recent clearances: My Dose Coach
1
Total
1
Cleared
0
Denied
Sanofi, is an R&D-driven, AI-powered biopharmaceutical company committed to improving people's lives through innovative medicines and vaccines. The company operates with a manufacturing facility in Cambridge, US, and maintains a global presence across multiple therapeutic areas including neurology, oncology, rare diseases, immunology, and vaccines.
Sanofi has received 1 FDA 510(k) clearance from 1 total submission, with its cleared device in the General Hospital category. The company's regulatory activity in this space dates to 2017. As no clearances have been granted in more than five years, this represents a historical record of the company's medical device portfolio.
The cleared device, My Dose Coach, reflects Sanofi's broader commitment to patient engagement and healthcare solutions. Explore the device name, product code, and clearance date in the full regulatory database.
FDA 510(k) Regulatory Record - Sanofi
1 devices