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Gainor Medical Europe, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K926448I.V. ADMINISTRATION SETMay 2, 1994
K931828CARELET SAFETY LANCETOctober 15, 1993
K931827CLEANLET, CLEANLET XL & KIDSSeptember 13, 1993
K922441SURESEAL BANDAGEAugust 10, 1993
K913333I.V. PRIMING SETOctober 23, 1991
K902422NEEDLE, ASPIRATION & INJECTION, DISPOSABLEJune 6, 1991
K902420CATHETER, NASAL, OXYGENApril 17, 1991
K902564NEEDLE, DIALYSISMarch 1, 1991
K902421STOMACH, GASTRO-ENTEROSTOMYNovember 20, 1990
K902426HEMODIALYSIS SYSTEM AND ACCESSORYNovember 20, 1990
K902416SURELITE AND SURELITE XL BLOOD LANCETAugust 1, 1990
K902417BAG, URINEJuly 16, 1990
K900306HEMODIALYSIS BLOOD LINESApril 20, 1990