Medical Device Manufacturer · US , Natick , MA

Direx Systems Corp. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2003

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Direx Systems Corp. Gastroenterology & Urology ✕

7 devices

1-7 of 7

Cleared Mar 01, 2012

Gastroenterology & Urology · 237d

Cleared Oct 20, 2006

Gastroenterology & Urology · 85d

Cleared Mar 01, 2006

Gastroenterology & Urology · 61d

Cleared Mar 16, 2005

TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)

Gastroenterology & Urology · 61d

Cleared Jul 07, 2004

MODIFICATION TO TRIPTER X-1 COMPACT DUET

Gastroenterology & Urology · 23d

Cleared Apr 28, 2004

TRIPTER X-1 COMPACT

Gastroenterology & Urology · 64d

Cleared Jan 17, 2003

TRIPTER X-1 COMPACT DUET

Gastroenterology & Urology · 88d