Olympus America, Inc. - FDA 510(k) Cleared Devices
149
Total
149
Cleared
0
Denied
149 devices
Cleared
May 02, 2002
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
Gastroenterology & Urology
30d
Cleared
May 01, 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
Ear, Nose, Throat
29d
Cleared
Feb 08, 2002
OLYMPUS HDL CHOLESTEROL REAGENT
Chemistry
65d
Cleared
Feb 08, 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS...
Chemistry
64d
Cleared
Dec 11, 2001
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
Gastroenterology & Urology
90d
Cleared
Aug 27, 2001
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC...
Radiology
73d
Cleared
Jun 25, 2001
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
Chemistry
21d
Cleared
Feb 27, 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
Gastroenterology & Urology
264d
Cleared
Dec 18, 2000
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
Chemistry
14d
Cleared
Oct 25, 2000
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
Immunology
36d
Cleared
Oct 25, 2000
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
Chemistry
30d
Cleared
Sep 05, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
Radiology
274d
Cleared
Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
Radiology
183d
Cleared
Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
Radiology
179d
Cleared
Nov 03, 1999
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
Gastroenterology & Urology
170d
Cleared
Sep 17, 1999
OLYMPUS DISTAL ATTACHMENT, MODELS...
Gastroenterology & Urology
284d
Cleared
Aug 19, 1999
OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
Toxicology
59d
Cleared
Jul 12, 1999
TROCAR SYSTEM ACCORDING TO HASSON
General & Plastic Surgery
169d
Cleared
May 11, 1999
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
Immunology
36d
Cleared
Feb 24, 1999
BIPOLAR GRASPING FORCEPS BIQ+
General & Plastic Surgery
76d
Cleared
Dec 11, 1998
OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR...
Radiology
162d
Cleared
Oct 23, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
Radiology
79d
Cleared
Aug 19, 1998
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
Gastroenterology & Urology
50d
Cleared
Jun 09, 1998
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
Chemistry
22d
Cleared
May 07, 1998
OLYMPUS SERUM PROTEIN MULTICALIBRATOR
Chemistry
27d
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