FDA 510(k) Applications Submitted by OLYMPUS AMERICA, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K954451 09/25/1995 EVIS 140 SYSTEM OLYMPUS AMERICA, INC.
K960068 01/05/1996 SH-1 SURGICAL HOLDER FOR TELESCOPE OLYMPUS AMERICA, INC.
K950719 02/16/1995 OES UROLOGY OLYMPUS AMERICA, INC.
K961048 03/15/1996 OLYMPUS MH-246R BALLOON SHEATH OLYMPUS AMERICA, INC.
K961611 04/25/1996 OLYMPUS BASKET GRASPERS (UROLOGY) OLYMPUS AMERICA, INC.
K951994 04/28/1995 OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER OLYMPUS AMERICA, INC.
K961860 05/14/1996 A4907 LENS CLEANING SHEATH OLYMPUS AMERICA, INC.
K962367 06/19/1996 OLYMPUS BASKET GRASPERS OLYMPUS AMERICA, INC.
K962387 06/20/1996 OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) OLYMPUS AMERICA, INC.
K962380 06/20/1996 OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) OLYMPUS AMERICA, INC.
K962378 06/20/1996 OLYMPUS FG-45/46-1 GRASPING FORCEPS OLYMPUS AMERICA, INC.
K952892 06/23/1995 OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) OLYMPUS AMERICA, INC.
K962474 06/25/1996 OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) OLYMPUS AMERICA, INC.
K962485 06/26/1996 OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) OLYMPUS AMERICA, INC.
K962533 06/28/1996 OLYPUS FG SERIES GRASPING FORCEPS OLYMPUS AMERICA, INC.
K962555 07/01/1996 OLYMPUS FB SERIES BIOPSY FORCEPS OLYMPUS AMERICA, INC.
K962901 07/25/1996 OLYMPUS B5-2C/B7-2C BALLOON CATHETER OLYMPUS AMERICA, INC.
K962925 07/29/1996 OLYMPUS B-5/B-7 SERIESBALLOON CATHETER OLYMPUS AMERICA, INC.
K963033 08/05/1996 BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES OLYMPUS AMERICA, INC.
K963184 08/14/1996 OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM OLYMPUS AMERICA, INC.
K963160 08/14/1996 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE OLYMPUS AMERICA, INC.
K954488 09/27/1995 ROLLER ELECTRODE OLYMPUS AMERICA, INC.
K955063 11/06/1995 OLYMPUS BASKET GRASPERS OLYMPUS AMERICA, INC.
K955066 11/06/1995 OLYMPUS FG SERIES GRASPING FORCEPS OLYMPUS AMERICA, INC.
K955065 11/06/1995 OLYMPUS FB SERIES BIOPSY FORCEPS OLYMPUS AMERICA, INC.
K955404 11/27/1995 OTV-S5 OES VIDEO SYSTEM OLYMPUS AMERICA, INC.
K955403 11/27/1995 OES LAPARO-THORACO VIDEOSCOPE TYPE V OLYMPUS AMERICA, INC.
K955456 11/29/1995 OES LAPARO-THORACO VIDEOSCOPE (RIGID) OLYMPUS AMERICA, INC.
K955623 12/11/1995 OLYMPUS BIPOLAR FORCEPS OLYMPUS AMERICA, INC.
K955650 12/12/1995 OLYMPUS SD SERIES SNARES OLYMPUS AMERICA, INC.
K963023 08/05/1996 ULTRASOUND GASTROSCOPE GF TYPE UM30P OLYMPUS AMERICA, INC.
K060201 01/26/2006 OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. OLYMPUS AMERICA, INC.
K061575 06/07/2006 OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 OLYMPUS AMERICA, INC.
K051564 06/14/2005 OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH OLYMPUS AMERICA, INC.
K041793 07/02/2004 OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 OLYMPUS AMERICA, INC.
K042406 09/03/2004 OLYMPUS LACTATE, OSR6193 OLYMPUS AMERICA, INC.
K062862 09/25/2006 OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 OLYMPUS AMERICA, INC.
K043202 11/18/2004 OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 OLYMPUS AMERICA, INC.
K043460 12/15/2004 OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 OLYMPUS AMERICA, INC.
K063804 12/22/2006 OLYMPUS TRIGLYCERIDE TEST SYSTEM OLYMPUS AMERICA, INC.
K062581 08/31/2006 OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM OLYMPUS AMERICA, INC.
K980465 02/05/1998 OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS OLYMPUS AMERICA, INC.
K982725 08/05/1998 OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE OLYMPUS AMERICA, INC.
K990237 01/24/1999 TROCAR SYSTEM ACCORDING TO HASSON OLYMPUS AMERICA, INC.
K961274 04/02/1996 OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC.
K021073 04/02/2002 VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V OLYMPUS AMERICA, INC.
K021074 04/02/2002 VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA OLYMPUS AMERICA, INC.
K981305 04/10/1998 OLYMPUS SERUM PROTEIN MULTICALIBRATOR OLYMPUS AMERICA, INC.
K971817 05/16/1997 OLYMPUS CK-MB REAGENT OLYMPUS AMERICA, INC.
K991672 05/17/1999 OLYMPUS NA-10J-KB ASPIRATION NEEDLE OLYMPUS AMERICA, INC.
K981743 05/18/1998 OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC.
K061499 05/31/2006 OSFERION OLYMPUS AMERICA, INC.
K001744 06/08/2000 OLYMPUS ENDOSCOPIC LIGATION DEVICE OLYMPUS AMERICA, INC.
K051541 06/10/2005 GF-UE160-AL5 ULTRASOUND ENDOSCOPE OLYMPUS AMERICA, INC.
K011886 06/15/2001 OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, OLYMPUS AMERICA, INC.
K962409 06/21/1996 OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT OLYMPUS AMERICA, INC.
K992086 06/21/1999 OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 OLYMPUS AMERICA, INC.
K982289 06/30/1998 HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## OLYMPUS AMERICA, INC.
K962582 07/01/1996 OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT OLYMPUS AMERICA, INC.
K982323 07/02/1998 OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE OLYMPUS AMERICA, INC.
K963139 08/12/1996 OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT OLYMPUS AMERICA, INC.
K963170 08/14/1996 OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT OLYMPUS AMERICA, INC.
K963424 08/30/1996 OLYMPUS LIPASE REAGENT OLYMPUS AMERICA, INC.
K963640 09/12/1996 OLYMPUS ACID PHOSPHATASE REAGENT OLYMPUS AMERICA, INC.
K013066 09/12/2001 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE OLYMPUS AMERICA, INC.
K954537 09/29/1995 OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT OLYMPUS AMERICA, INC.
K955139 11/13/1995 OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT OLYMPUS AMERICA, INC.
K994069 12/02/1999 OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE OLYMPUS AMERICA, INC.
K994103 12/06/1999 OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT OLYMPUS AMERICA, INC.
K984358 12/07/1998 OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 OLYMPUS AMERICA, INC.
K984417 12/10/1998 BIPOLAR GRASPING FORCEPS BIQ+ OLYMPUS AMERICA, INC.
K955752 12/19/1995 OLYMPUS URIC ACID REAGENT OLYMPUS AMERICA, INC.
K991136 04/05/1999 B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM OLYMPUS AMERICA, INC.
K994106 12/06/1999 OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE OLYMPUS AMERICA, INC.
K030045 01/06/2003 OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) OLYMPUS AMERICA, INC.
K030124 01/14/2003 OLYMPUS FERRITIN REAGENT OLYMPUS AMERICA, INC.
K040471 02/24/2004 OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 OLYMPUS AMERICA, INC.
K040692 03/17/2004 OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 OLYMPUS AMERICA, INC.
K031380 05/01/2003 OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) OLYMPUS AMERICA, INC.
K011720 06/04/2001 OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC.
K032285 07/24/2003 OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 OLYMPUS AMERICA, INC.
K032665 08/28/2003 OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 OLYMPUS AMERICA, INC.
K002918 09/19/2000 OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT OLYMPUS AMERICA, INC.
K002982 09/25/2000 OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC.
K003721 12/04/2000 MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC.
K014015 12/05/2001 OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA OLYMPUS AMERICA, INC.
K014032 12/06/2001 OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA OLYMPUS AMERICA, INC.
K111788 06/24/2011 ENDOEYE HD II OLYMPUS AMERICA, INC.
K081615 06/09/2008 OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN OLYMPUS AMERICA, INC.
K955052 11/06/1995 OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS OLYMPUS AMERICA, INC.
K955051 11/06/1995 OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS OLYMPUS AMERICA, INC.
K955247 11/15/1995 OLYMPUS KD SERIES SPHINCTEROTOME OLYMPUS AMERICA, INC.
K964661 11/20/1996 HX-20/21-1 ENDOSCOPIC LIGATOR OLYMPUS AMERICA, INC.
K970184 01/17/1997 OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES OLYMPUS AMERICA, INC.
K970563 02/13/1997 OLYMPUS NA-10J-1 ASPIRATION NEEDLE OLYMPUS AMERICA, INC.
K970797 03/04/1997 OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES OLYMPUS AMERICA, INC.
K971328 04/10/1997 OLYMPUS CD-6C-1 COAGULATION ELECTRODE OLYMPUS AMERICA, INC.
K971416 04/16/1997 OLYMPUS OES OTV-S5C VIDEO SYSTEM OLYMPUS AMERICA, INC.
K971660 05/06/1997 OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT OLYMPUS AMERICA, INC.
K973128 08/21/1997 OLYMPUS NA-10J-1 ASPIRATION NEEDLE OLYMPUS AMERICA, INC.


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