Olympus America Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
149
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2807-2015Class IIEVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be uMarch 26, 2015
Z-0432-2014Class IITB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TBSeptember 27, 2013
Z-0329-2014Class IIOlympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feMay 20, 2013
Z-1277-2013Class IIOlympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a mNovember 10, 2009

Recent 510(k) Clearances

K-NumberDeviceDate
K111788ENDOEYE HD IIJanuary 13, 2012
K081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENMarch 18, 2009
K073489OLYMPUS IGA REAGENTFebruary 11, 2008
K073487OLYMPUS IGM REAGENTFebruary 11, 2008
K073490OLYMPUS IGG REAGENTFebruary 11, 2008
K062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98April 6, 2007
K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMMarch 23, 2007
K061499OSFERIONJanuary 26, 2007
K062581OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEMNovember 29, 2006
K061575OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117October 5, 2006
K060201OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.June 6, 2006
K051564OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LAAugust 22, 2005
K051541GF-UE160-AL5 ULTRASOUND ENDOSCOPEJuly 1, 2005
K043460OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071January 31, 2005
K043202OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279December 23, 2004
K042406OLYMPUS LACTATE, OSR6193December 3, 2004
K041668OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENTAugust 19, 2004
K041793OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524July 16, 2004
K040692OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023April 8, 2004
K040471OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024March 10, 2004