Spectral Medical, Inc. is one of 434 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Spectral Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Endotoxin Activity Assay (EAA), SAM CRRT Unit, SAM Cassette CRRT
2
Total
2
Cleared
0
Denied
Spectral Medical, Inc. has 2 FDA 510(k) cleared medical devices. Based in Toronto, CA.
Historical record: 2 cleared submissions from 2017 to 2019. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Spectral Medical, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Amarex Clinical Research as regulatory consultant.
FDA 510(k) Regulatory Record - Spectral Medical, Inc.
2 devices