Medical Device Manufacturer · US , Richland , MI

Imagyn Surgical - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 1999

Recent clearances: 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE

3

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Imagyn Surgical Cardiovascular ✕

1 devices

1-1 of 1

Cleared Apr 29, 2003

ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR

Cardiovascular · 382d