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Warne Surgical Products, Ltd.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K850694WSP CODE 4310 STRESSCATHMay 17, 1985
K850696WSP CODE 4300 DIOMASTER DIAGNOSTICMay 17, 1985
K850695WSP CODE 4301 DIOMASTER THERAPEUTICMay 16, 1985
K850693WSP CODE 4315 PADTESTMay 10, 1985
K841511HAEMATURIA CATHETERSJuly 12, 1984
K840687KIDNEY TRANSPLANT CATHETERJune 7, 1984
K841411ROLLED NECK W/PLUGApril 18, 1984
K841410BUSH NECK W/TAPApril 18, 1984
K841409BUSH NECK W/PLUGApril 18, 1984
K841412ROLLED NECK W/TAPApril 18, 1984
K840702SECURE W/25MM DIAM. SHEATH & ADHESIVEMarch 22, 1984
K840704SECURE W/35MM DIAM, SHEATH/ADHESIVEMarch 22, 1984
K840703SECURE W/30MM DIAM, SHEATH & ADHESIVEMarch 22, 1984
K834536CRYSTALCONE FACE MASK-MED-W/HOOKRINGJanuary 25, 1984
K834454PAEDIATRIC FACE MASK 1-3 W/WO RINGJanuary 18, 1984