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Olympus Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
144
Inspections
0
Compliance Actions
0

Known Names

olympus winter and ibe, olympus corporation of the americas, olympus, olympus australia, olympus europa se and co kg, olympus keymed (medical and industrial equipment) lt, olympus life and material science europa gmbh (irish

Recent 510(k) Clearances

K-NumberDeviceDate
K915402EW-10 AND EW-20June 23, 1995
K933200OLYMPUS PBD STENTSApril 5, 1995
K942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESNovember 30, 1994
K931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSAugust 29, 1994
K934835FLOVALJune 21, 1994
K931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCESJune 8, 1994
K915857FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPEMarch 11, 1994
K931994RESECTOSCOPE SHEATHFebruary 17, 1994
K934889OLYMPUS IMAGEMANAGER SYSTEMJanuary 28, 1994
K934888OLYMPUS IMAGEMANAGERSYSTEMJanuary 25, 1994
K933992OLYMPUS SCLEROTHERAPY BALLOONDecember 21, 1993
K934361OLYMPUS CREATININE REAGENTNovember 16, 1993
K934136OLYMPUS CHLORIDE REAGENT, MODIFICATIONNovember 5, 1993
K933110OLYMPUS GUIDE WIRENovember 4, 1993
K933717OLYMPUS MEASURING DEVICESNovember 2, 1993
K931301OLYMPUS AMYLASE REAGENTOctober 18, 1993
K931154EVIS 200 SYSTEMOctober 7, 1993
K931939OLYMPUS CREATININE REAGENTSeptember 21, 1993
K932528OLYMPUS CHLORID REAGENT, MODIFIEDSeptember 17, 1993
K931835OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENTSeptember 8, 1993