Medical Device Manufacturer · US , Lake Success , NY

Olympus America, Inc. - FDA 510(k) Cleared Devices

149 submissions · 149 cleared · Since 1994
149
Total
149
Cleared
0
Denied
FDA 510(k) Regulatory Record - Olympus America, Inc. Radiology
15 devices
1-15 of 15
Cleared Jul 01, 2005
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
K051541 · FDF
Radiology · 21d
Cleared Aug 27, 2001
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC...
K011886 · ODG
Radiology · 73d
Cleared Sep 05, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994103 · ITX
Radiology · 274d
Cleared Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994069 · ITX
Radiology · 183d
Cleared Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994106 · ITX
Radiology · 179d
Cleared Dec 11, 1998
OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR...
K982323 · ITX
Radiology · 162d
Cleared Oct 23, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
K982725 · ITX
Radiology · 79d
Cleared Jul 25, 1997
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND...
K971660 · FDS
Radiology · 80d
Cleared Feb 07, 1997
ULTRASOUND GASTROSCOPE GF TYPE UM30P
K963023 · FDS
Radiology · 186d
Cleared Sep 16, 1996
OLYMPUS MH-246R BALLOON SHEATH
K961048 · ODG
Radiology · 185d
Cleared Apr 15, 1996
OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER
K951994 · IYO
Radiology · 353d
Cleared Feb 12, 1996
OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)
K952892 · ITX
Radiology · 234d
Cleared Sep 18, 1995
OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS
K952888 · LMB
Radiology · 87d
Cleared Jun 13, 1995
OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM
K944017 · ITX
Radiology · 301d
Cleared Apr 10, 1995
OLYMPUS ULTRASONIC PROBES
K944610 · ITX
Radiology · 203d
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