Olympus Corp. - FDA 510(k) Cleared Devices
142
Total
140
Cleared
0
Denied
142 devices
Cleared
Aug 24, 1990
BC BRUSHES
Gastroenterology & Urology
64d
Cleared
Aug 22, 1990
PR CANNULAS
Gastroenterology & Urology
62d
Cleared
Aug 02, 1990
SD SNARES
General & Plastic Surgery
42d
Cleared
Jul 10, 1990
CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA.
Chemistry
103d
Cleared
Apr 25, 1990
CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY
Chemistry
36d
Cleared
Mar 16, 1990
OLYMPUS HYSTERORESECTOSCOPE
Obstetrics & Gynecology
88d
Cleared
Jan 02, 1990
OLYMPUS VALVULOTOME W/DETACHABLE TIP
Cardiovascular
89d
Cleared
Oct 12, 1989
OLYMPUS VALVULOTOME W/FIXED TIP
Cardiovascular
85d
Cleared
Oct 02, 1989
OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE
Obstetrics & Gynecology
201d
Cleared
Aug 15, 1989
MODIFIED PK300 AUTOMATIC EIA ANALYZER
Chemistry
88d
Cleared
Aug 11, 1989
OLYMPUS ISE MODULE FOR AU5000
Chemistry
92d
Cleared
Feb 03, 1989
OLYMPUS ISE MODULE
Chemistry
49d
Cleared
Jan 10, 1989
ANGIOPUMP TUBING SET
Cardiovascular
89d
Cleared
Nov 15, 1988
OLYMPUS GF-UM3/EU-M3
Gastroenterology & Urology
183d
Cleared
Sep 08, 1988
OLYMPUS REPLY CHEMISTRY ANALYZER
Chemistry
86d
Cleared
Feb 29, 1988
OLYMPUS ANGIOSCOPY SHEATH
Cardiovascular
206d
Cleared
Nov 30, 1987
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
Cardiovascular
224d
Cleared
Nov 30, 1987
OLYMPUS LUS ULTRASONIC LITHOTRIPTER
Gastroenterology & Urology
101d
Cleared
Aug 17, 1987
OLYMPUS GF-UM2/EU-M2
Radiology
83d
Cleared
Aug 12, 1987
OLYMPUS ANGIOSCOPY PUMP
General Hospital
125d
Cleared
Feb 20, 1987
OLYMPUS PK300
Chemistry
73d
Cleared
Nov 20, 1986
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
Cardiovascular
258d
Cleared
Sep 29, 1986
OLYMPUS AU 5000 FLAME PHOTOMETER MODULE
Chemistry
117d
Cleared
Jan 24, 1986
OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM
Chemistry
16d
Cleared
Jan 21, 1986
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
Gastroenterology & Urology
148d
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