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Orion Life Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K943835PRE-FILLED SYRINGE W/STERILE .25% ACETC ACIDJanuary 24, 1995
K943831PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATERNovember 21, 1994
K943832STERILE .9% SODIUM CHLORIDE FOR IRRATIONNovember 21, 1994
K943830PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTIONNovember 21, 1994
K943836PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATERNovember 21, 1994
K943834STERILE .9% SODIUM CHLORIDE SOLUTIONNovember 21, 1994
K943828STERILE WATER FOR IRRIGATIONNovember 21, 1994
K943829PRE-FILLED SYSRINGE W/STERILE WATERNovember 21, 1994
K943833STERILE WATER FOR IRRATIONNovember 1, 1994
K923168DUAL PORT ENTERAL Y-ADAPTORJune 17, 1994
K923497FLUSHING IRRIGATION SETMarch 21, 1994
K923156TRACHEOSTOMY CARE TRAYAugust 18, 1993
K923496URINARY CARE SUPPLIESMay 27, 1993
K904801ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBEJanuary 16, 1991
K903117ORION STERILE OR TOWELSDecember 31, 1990
K902813SHAVE PREP TRAYNovember 19, 1990
K902810STERILE I.V. START KITNovember 13, 1990
K902811ROUTINE DRESSING TRAYSeptember 25, 1990
K902814SUCTION CATHETER, STERILEAugust 17, 1990
K902828SUTURE REMOVAL TRAYAugust 8, 1990