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Telemed Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K020379PPD BALLOON DILATATION CATHETERMay 6, 2002
K013737MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOONMarch 1, 2002
K010412FLEXIBLE ENDOSCOPIC SCISSORSApril 2, 2001
K9924025.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTDecember 22, 1999
K992390HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIDecember 22, 1999
K974312REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS January 21, 1998
K974300TELEMED SYSTEMS RETRIEVAL BASKETDecember 19, 1997
K901435GASTROINTESTINAL CYTOLOGY BRUSHJuly 16, 1990
K901427BILIARY STONE RETRIEVAL AND OCCLUSION BALLOONJune 22, 1990
K901432BILIARY BALLOON DILATORJune 21, 1990
K901425PYLORIC BALLOON DILATORJune 21, 1990
K901433SURE-FLEX ANASTOMOTIC BALLOON DILATORJune 21, 1990
K901426COLONIC BALLOON DILATORJune 21, 1990
K901424ESOPHAGEAL BALLOON DILATORJune 21, 1990
K901431TELEMED ERCP CANNULAJune 18, 1990
K901436BRONCHIAL CYTOLOGY BRUSHJune 18, 1990
K901437TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLEJune 18, 1990
K901428DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNAREJune 18, 1990
K901439DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEANJune 11, 1990
K901434PAPILLOTOMEJune 8, 1990