Fortune Medical Instrument Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K022112FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020April 3, 2003
K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300February 12, 2003
K021142ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865October 1, 2002
K014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890March 4, 2002
K980917ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIRMay 27, 1998
K980919ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETERMarch 31, 1998