Medical Device Manufacturer · US , Phoenix , AZ

Amedic USA - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1987

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Amedic USA Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Aug 08, 1989

EXTENDED COVERS, STERILE

Gastroenterology & Urology · 130d

Cleared Aug 08, 1989

GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE

Gastroenterology & Urology · 130d

Cleared Aug 04, 1989

TRT (ACUSON) NEEDLE GUIDE KIT, STERILE

Gastroenterology & Urology · 127d

Cleared Aug 21, 1987

BIOPSY NEEDLE GUIDE KIT, STERILE

Gastroenterology & Urology · 129d