Medical Device Manufacturer · US , Hudson , MA

Telemed Systems, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1990

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Telemed Systems, Inc. Gastroenterology & Urology ✕

19 devices

1-12 of 19

Cleared May 06, 2002

PPD BALLOON DILATATION CATHETER

Gastroenterology & Urology · 90d

Cleared Mar 01, 2002

MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON

Gastroenterology & Urology · 108d

Cleared Apr 02, 2001

FLEXIBLE ENDOSCOPIC SCISSORS

Gastroenterology & Urology · 49d

Cleared Dec 22, 1999

HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED...

Gastroenterology & Urology · 156d

Cleared Dec 22, 1999

5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X...

Gastroenterology & Urology · 156d

Cleared Jan 21, 1998

REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE,...

Gastroenterology & Urology · 65d

Cleared Dec 19, 1997

TELEMED SYSTEMS RETRIEVAL BASKET

Gastroenterology & Urology · 32d

Cleared Jul 16, 1990

GASTROINTESTINAL CYTOLOGY BRUSH

Gastroenterology & Urology · 112d

Cleared Jun 22, 1990

BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON

Gastroenterology & Urology · 88d

Cleared Jun 21, 1990

ESOPHAGEAL BALLOON DILATOR

Gastroenterology & Urology · 87d

Cleared Jun 21, 1990

PYLORIC BALLOON DILATOR

Gastroenterology & Urology · 87d

Cleared Jun 21, 1990

COLONIC BALLOON DILATOR

Gastroenterology & Urology · 87d