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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