Medical Device Manufacturer · US , Bedford , MA

Spectrawave, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2023

Total

Cleared

Denied

Spectrawave, Inc. has 6 FDA 510(k) cleared medical devices. Based in Bedford, US.

Latest FDA clearance: Dec 2025. Active since 2023. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Spectrawave, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Spectrawave, Inc.

6 devices

1-6 of 6