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
1-19 of 19
Cleared May 06, 2002
PPD BALLOON DILATATION CATHETER
K020379 · KNT
Gastroenterology & Urology · 90d
Cleared Mar 01, 2002
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
K013737 · FGE
Gastroenterology & Urology · 108d
Cleared Apr 02, 2001
FLEXIBLE ENDOSCOPIC SCISSORS
K010412 · OCZ
Gastroenterology & Urology · 49d
Cleared Dec 22, 1999
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED...
K992390 · KGE
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...
K992402 · KNS
Gastroenterology & Urology · 156d
Cleared Jan 21, 1998
REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE,...
K974312 · KNW
Gastroenterology & Urology · 65d
Cleared Dec 19, 1997
TELEMED SYSTEMS RETRIEVAL BASKET
K974300 · OCZ
Gastroenterology & Urology · 32d
Cleared Jul 16, 1990
GASTROINTESTINAL CYTOLOGY BRUSH
K901435 · FDX
Gastroenterology & Urology · 112d
Cleared Jun 22, 1990
BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
K901427 · FGE
Gastroenterology & Urology · 88d
Cleared Jun 21, 1990
ESOPHAGEAL BALLOON DILATOR
K901424 · KNQ
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
PYLORIC BALLOON DILATOR
K901425 · FAT
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
COLONIC BALLOON DILATOR
K901426 · FFP
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
BILIARY BALLOON DILATOR
K901432 · FGE
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
SURE-FLEX ANASTOMOTIC BALLOON DILATOR
K901433 · FGE
Gastroenterology & Urology · 87d
Cleared Jun 18, 1990
DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE
K901428 · FDI
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
TELEMED ERCP CANNULA
K901431 · FGE
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
BRONCHIAL CYTOLOGY BRUSH
K901436 · FDX
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE
K901437 · FBK
Gastroenterology & Urology · 84d
Cleared Jun 05, 1990
SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE
K901429 · OCY
Gastroenterology & Urology · 71d
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