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Medisystems Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K062953MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICEFebruary 12, 2007
K010279MEDISYSTEMS LUER ACCESS INJECTION SITEMay 29, 2001
K002372ACCESS ALERT GAUGEOctober 25, 2000
K994306REVERSOMarch 20, 2000
K990803MEDISYSTEMS BUTTONHOLE NEEDLE SETSJanuary 6, 2000
K983076MEDISYSTEMS TRANSDUCER PROTECTORNovember 25, 1998
K971860MEDISYSTEMS DIALYSIS PRIMING SETSAugust 18, 1997
K963668MEDISYSTEMS PERITONEAL DIALYSIS SETSAugust 15, 1997
K970536MEDISYSTEMS TRANDUCER PROTECTORMay 12, 1997
K953823ARTERIAL VENOUS BLOOD TUBING SETSeptember 23, 1996
K932074MEDISYSTEMS APHERESIS NEEDLE WITH GUARDFebruary 18, 1994
K910734MEDISYSTEMS HEMODIALYSIS FISTULA SETJune 20, 1991
K910733MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLEJune 6, 1991
K895856MEDISYSTEMS TRANSDUCER PROTECTORNovember 24, 1989
K862002MEDISYSTEMS PHERESIS NEEDLEJune 27, 1986
K823068MEDISYSTEMS FISTULA NEEDLESJanuary 26, 1983
K823069KF-E SERIES HOLLOW FIBER DIALYZERJanuary 21, 1983
K812910MEDISYSTEMS NEEDLES & SYRINGESNovember 6, 1981
K812353KF-E SERIES OF HOLLOW FIBER DIALYZERSSeptember 16, 1981
K811839MEDISYSTEM NEGATIVE PRESSURESeptember 8, 1981