Sigma Intl. is one of 25722 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Sigma Intl. - FDA 510(k) Cleared Devices
Recent clearances: SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY, SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/, SIGMA 8000 AND SIGMA 8002
3
Total
3
Cleared
0
Denied
Sigma Intl. has 3 FDA 510(k) cleared medical devices. Based in Medina, US.
Historical record: 3 cleared submissions from 1994 to 2004. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Sigma Intl. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Intertek Testing Services as regulatory consultant.
FDA 510(k) Regulatory Record - Sigma Intl.
3 devices