Medi-Globe Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K061222INJECTRA INJECTION NEEDLEJuly 3, 2006
K051247SONOTIP II ULTRASOUND NEEDLE SYSTEMJune 16, 2005
K011261STONE EXTRACTOR BALLOON CATHETERNovember 17, 2003
K010714EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830January 21, 2003
K010549BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)January 18, 2002
K990220MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEMMarch 31, 1999
K953355GIP/MEID-GLOBE HOT BIOPSY FORCEPSApril 4, 1996
K955558GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLESFebruary 29, 1996
K953827GIP/MEDI-GLOBE ERCP CATHETERSSeptember 1, 1995
K941973GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRESJune 30, 1995
K943935GIP/MEDI-GLOBE POLYPECTOMY SNARESMay 26, 1995
K943629GIP/MEDI-GLOBE PAPILLOTOMEMay 26, 1995
K935844GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNAFebruary 13, 1995
K943476GIP/MEDI-GLOBE GOREIGN BODY GRASPERSDecember 15, 1994
K942544GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETSNovember 22, 1994
K942005GIP/MED-GLOBE STONE EXTRACTOR BASKETSNovember 22, 1994
K941359GIP/MEDI-GLOBE BIOPSY FORCEPSJuly 12, 1994
K900459APPLICARD (EKG)July 31, 1990