Medical Device Manufacturer · US , Lake Success , NY

Olympus America, Inc.

149 submissions · 149 cleared · Since 1994
149
Total
149
Cleared
0
Denied

Olympus America, Inc. — FDA 510(k) Submissions

Olympus America, Inc. has submitted 149 FDA 510(k) premarket notifications since 1994, of which 149 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bronchoscope (flexible Or Rigid), Laparoscope, General & Plastic Surgery, Laparoscope, Gynecologic (and Accessories), Transducer, Ultrasonic, Diagnostic, Calibrator, Secondary . Use the specialty filter in the sidebar to narrow results.

149 devices
1–12 of 149
ENDOEYE HD II
K111788 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Jan 2012 203d
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
K081615 · DHX System, Test,... · Immunology
Mar 2009 282d
OLYMPUS IGM REAGENT
K073487 · CFN Method, Nephelometric,... · Immunology
Feb 2008 61d
OLYMPUS IGA REAGENT
K073489 · CFN Method, Nephelometric,... · Immunology
Feb 2008 61d
OLYMPUS IGG REAGENT
K073490 · CFN Method, Nephelometric,... · Immunology
Feb 2008 61d
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
K062862 · KNK Acid, Uric, Uricase... · Chemistry
Apr 2007 193d
OLYMPUS TRIGLYCERIDE TEST SYSTEM
K063804 · CDT Lipase... · Chemistry
Mar 2007 91d
OSFERION
K061499 · MQV Filler, Bone Void,... · Orthopedic
Jan 2007 240d
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
K062581 · JLW Radioimmunoassay,... · Chemistry
Nov 2006 90d
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
K061575 · CJY Azo Dye, Calcium · Chemistry
Oct 2006 120d
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
K060201 · DHR System, Test, Rheumatoid... · Immunology
Jun 2006 131d
OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
K051564 · NQD Cardiac C-reactive... · Chemistry
Aug 2005 69d

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