Puritan Medical Products, LLC - FDA 510(k) Cleared Devices

Puritan Medical Products, LLC is an American family-owned manufacturer known worldwide for specimen collection and transport systems. The company operates with a manufacturing facility in Guilford, Maine, and specializes in Microbiology devices for diagnostics and clinical applications.

Puritan has received 7 FDA 510(k) clearances from 7 total submissions since 2012. The company's regulatory portfolio focuses entirely on Microbiology devices, including collection and transport systems with various culture media formulations. The latest clearance in 2025 demonstrates continued product innovation and active regulatory engagement.

Recent cleared devices include collection and transport systems featuring Amies medium, Cary-Blair medium, and Stuart medium, as well as specialized fecal collection kits. These products support specimen integrity and diagnostic accuracy across clinical microbiology laboratories.

Explore the full list of device names, product codes, and clearance dates in the 510(k) database.