Thermo Fisher Scientific - FDA 510(k) Cleared Devices

Thermo Fisher Scientific is a global life science and clinical research company based in Waltham, Massachusetts. The company operates a facility in Noble Park, Australia, providing scientific consumables, equipment, and services worldwide.

Thermo Fisher has received 64 FDA 510(k) clearances from 64 total submissions since 2007. The company specializes primarily in Microbiology devices, which represent 89% of its regulatory submissions. Recent clearances include multiple Sensititre susceptibility systems for antimicrobial testing. The latest FDA 510(k) clearance was granted in 2025, demonstrating continued regulatory activity.

Thermo Fisher Scientific ranks among the world's largest life science providers, with 2024 annual revenue of $42.879 billion. The company supplies analytical instruments, clinical development solutions, specialty diagnostics, and laboratory services globally. Recent acquisitions and strategic investments underscore its commitment to expanding manufacturing capacity and research capabilities in the United States.

Explore the complete regulatory record, including device names, product codes, and clearance dates, to learn more about Thermo Fisher's FDA 510(k) submissions and cleared devices.