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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
K854857SCALPEL, ONE-PIECE, DISPOSABLEDecember 24, 1985
K854858SCALPEL HANDLEDecember 24, 1985
K854860BLADES, SCALPEL CARBON STEETDecember 24, 1985
K854859BLADES, SCALPEL STAINLESS STEELDecember 24, 1985
K854563DISPOSABLE SYRINGES & NEEDLESDecember 9, 1985
K854561BLADE, SCALPELDecember 2, 1985