Medical Device Manufacturer · US , Mahwah , NJ

Dantec Medical, Inc. - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 1990

25

Total

25

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dantec Medical, Inc. Gastroenterology & Urology ✕

9 devices

1-9 of 9

Cleared Sep 16, 1996

Gastroenterology & Urology · 227d

Cleared Nov 21, 1995

Gastroenterology & Urology · 89d

Cleared Feb 22, 1993

CAVERNOSOMETRY MODULE FOR MENUET

Gastroenterology & Urology · 241d

Cleared Jan 23, 1992

DANTEC UD 5500 MK2

Gastroenterology & Urology · 190d

Cleared Jan 07, 1992

PULLER OPTION FOR ETUDE(TM)

Gastroenterology & Urology · 68d

Cleared Dec 09, 1991

Gastroenterology & Urology · 173d

Cleared Sep 23, 1991

ETUDE (MODEL NUMBERS 24A05 & 24A06)

Gastroenterology & Urology · 60d

Cleared Oct 26, 1990

ETUDE, URODYNAMIC INVESTIGATION SYSTEM

Gastroenterology & Urology · 211d

Cleared May 03, 1990

Gastroenterology & Urology · 164d