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Surgikos, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
56
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K875107HEALTH CARE EYE PROTECTIONMarch 21, 1988
K874653STERILE SURGICAL SCRUB BRUSHDecember 30, 1987
K861441NEUTRALON SURGICAL GLOVESMay 30, 1986
K852870BARRIER SURGICAL GOWNJuly 23, 1985
K822535CIDEX*DIALYZER DISINFECTING SOLUTIONSeptember 30, 1982
K820543BARRIER ANTIMICROBIAL INCISE DRAPEJuly 22, 1982
K820542SURGIKOS INCISE DRAPEJune 2, 1982
K811871BACTERICIDAL INCISE DRAPEAugust 20, 1981
K810316SURGIKOS FACE MASKFebruary 23, 1981
K801864BARRIER APERTURED DRAPEAugust 20, 1980
K801863BARRIER TOWEL DRAPEAugust 20, 1980
K800152SURGIKOS NEUTRALON BR. SURGEON'S GLOVEFebruary 19, 1980
K791719BARRIER & FACE MASK WITH INNER FACINGOctober 4, 1979
K791486FABRIC 450* TOWEL DRAPEAugust 28, 1979
K791439BARRIER* OVERHEAD TABLE DRAPEAugust 28, 1979
K791440BARRIER* X-RAY CASSETTE DRAPEAugust 28, 1979
K791438BARRIER* C-ARM DRAPEAugust 28, 1979
K791500BARRIER *450* TAPE STRIPAugust 28, 1979
K791032CARDIAC CATHETERIZATION SHEETS/PACKSJune 15, 1979
K790804PURGE LINE UNITMay 25, 1979