Telemed Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PPD BALLOON DILATATION CATHETER, MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON, FLEXIBLE ENDOSCOPIC SCISSORS
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Telemed Systems, Inc. Gastroenterology & Urology ✕
19 devices
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