Sigma - FDA 510(k) Cleared Devices

Sigma, is a medical device manufacturer with a registered facility in the US. The company developed devices across multiple therapeutic areas including general hospital equipment, hematology media, and physical medicine products.

Sigma received 6 FDA 510(k) clearances from 6 total submissions, with clearances spanning from 1983 to 1997. The company's cleared devices included infusion pumps for general hospital use, specialized culture media for hematology applications, and physical medicine adjustment systems. Sigma is no longer active in the medical device market, with no submissions recorded since 1997, and should be treated as a historical regulatory record.

Notable cleared products included the SIGMA 7000 and SIGMA 7000-6000 infusion pump systems for general hospital settings, MCDB culture media formulations for hematology research and diagnostics, and the SMART ADJUSTER device for physical medicine applications.

Explore the complete device names, product codes, and clearance dates in the FDA 510(k) database to review Sigma's full regulatory history.