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

Denied

Olympus America, Inc. has 149 FDA 510(k) cleared medical devices. Based in Lake Success, US.

Historical record: 149 cleared submissions from 1994 to 2012.

Browse the FDA 510(k) cleared devices submitted by Olympus America, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Olympus America, Inc.

149 devices

1-12 of 149

1 2 3 4

Cleared Jan 13, 2012

ENDOEYE HD II

K111788 · HET

Obstetrics & Gynecology · 203d

Cleared Mar 18, 2009

OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN

OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

K062862 · KNK

Chemistry · 193d

Cleared Mar 23, 2007

OLYMPUS TRIGLYCERIDE TEST SYSTEM

OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM

K062581 · JLW

Chemistry · 90d

Cleared Oct 05, 2006

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117

K061575 · CJY

Chemistry · 120d

Cleared Jun 06, 2006

OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S):...

K060201 · DHR

Immunology · 131d

Cleared Aug 22, 2005

OLYMPUS CRP LATEX REAGENT, OSR6199

K051564 · NQD

Chemistry · 69d

1 2 3 4

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

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