Medical Device Manufacturer · US , Pittsburgh , PA

Dymax Corp - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1985

Recent clearances: SITE-RITE IV ULTRASOUND SYSTEM, SITE-RITE 3 ULTRASOUND SYSTEM, SITERITE NEEDLE GUIDE (MODIFIED)

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dymax Corp Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jul 27, 1993

SITERITE NEEDLE GUIDE (MODIFIED)

Cardiovascular · 130d

Cleared Sep 27, 1990

SITERITE NEEDLE GUIDE

Cardiovascular · 71d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 11, 2026