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

1-12 of 15

Cleared Jul 01, 2005

GF-UE160-AL5 ULTRASOUND ENDOSCOPE

Radiology · 21d

Cleared Aug 27, 2001

OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC...

Radiology · 73d

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 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 Jul 25, 1997

OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND...

Radiology · 80d

Cleared Feb 07, 1997

ULTRASOUND GASTROSCOPE GF TYPE UM30P

Radiology · 186d

Cleared Sep 16, 1996

OLYMPUS MH-246R BALLOON SHEATH

Radiology · 185d

Cleared Apr 15, 1996

OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER

Radiology · 353d

Cleared Feb 12, 1996

OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)

Radiology · 234d