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Medelec Intl. Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K961013DISPOSABLE NEEDLE ELECTRODEDecember 20, 1996
K935017TD50 ELECTROMYOGRAPHJuly 28, 1994
K922548MEDELEC 2110 AND 2114 EEGNovember 3, 1992
K920127ELECTROENCEPHALOGRAPH RECORDING SYSTEMJune 10, 1992
K912775SAPPHIRE 4ME EMG/EP SYSTEMNovember 8, 1991
K865106PROPHYLACTIC (CONDOM) MR. JOHNNYMay 20, 1987
K863491BLOOD SPECIMEN COLLECTION DEVICESOctober 24, 1986
K854622PROPHYLACTIC (CONDOM)April 11, 1986
K854562CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS IJanuary 9, 1986
K854858SCALPEL HANDLEDecember 24, 1985
K854860BLADES, SCALPEL CARBON STEETDecember 24, 1985
K854859BLADES, SCALPEL STAINLESS STEELDecember 24, 1985
K854857SCALPEL, ONE-PIECE, DISPOSABLEDecember 24, 1985
K854563DISPOSABLE SYRINGES & NEEDLESDecember 9, 1985
K854561BLADE, SCALPELDecember 2, 1985