Medical Device Manufacturer · US , Stoughton , MA

Std Mfg., Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1993

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Std Mfg., Inc. General & Plastic Surgery ✕

4 devices

1-4 of 4

Cleared Aug 23, 2001

MODIFICATION TO VASCULAR CLOSURE DEVICE

General & Plastic Surgery · 29d

Cleared Dec 08, 2000

VASCULAR CLOSURE DEVICE

General & Plastic Surgery · 59d

Cleared Mar 07, 2000

SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM

General & Plastic Surgery · 13d

Cleared Jun 01, 1993

STD IRRIGATION PUMP

General & Plastic Surgery · 126d