Medi-Tech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
36
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K954457MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETERMay 15, 1996
K952345MEDI-TECH PLATFORM GUIDE CATHETERAugust 17, 1995
K952056IMMUNOASSAY DRUGS OF ABUSE CONTROLSJune 1, 1995
K945289DOA - IMMUNOASSAY CUT-OFF CALIBRATORDecember 13, 1994
K942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYEDOctober 6, 1994
K943290BILIRUBIN PLUS/PEDIATRIC CONTROLSSeptember 14, 1994
K922990HEMODIALYSIS BATHSeptember 12, 1994
K942552THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYEDSeptember 9, 1994
K904073COAGULATION REFERENCE PLASMA, ABNORMALOctober 22, 1990
K895819MODIFIED LABELING TO THE SPAND-GEL GRANULATED GELNovember 2, 1989
K873295PROSTATIC URETHRO. BALLOON DILATATION CATHETERJuly 31, 1989
K884354IMAGER FLUSH CATHETERSApril 21, 1989
K883880KATZEN THROMBOLYSIS GUIDEWIREApril 6, 1989
K884513PF TESTFebruary 3, 1989
K874096TITANIUM GREENFIELD VENA CAVA FILTER CARRIERNovember 4, 1988
K883118ON THE SPOT CANDIDASURESeptember 30, 1988
K880298PERIPHERAL DILATATION CATHETERApril 22, 1988
K864118MEDI-TECH SELECTIVE TORQUE CATHETERApril 9, 1987
K870729TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTERApril 9, 1987
K861599T-FASTENEROctober 2, 1986