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FDA-Registered Company Profile for OLYMPUS MEDICAL SYSTEMS CORPORATION
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| FDA-Supplied Establishment Information: |
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| Establishment Registration Number: |
8010047 |
| Company Name: |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Also Known As: |
ISHIKAWA FACILITY
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| Address: |
2951 ISHIKAWA-CHO |
| Address 2: |
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| City: |
HACHIOJI-SHI |
| State |
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| Zip / Postal Code: |
192-8507 |
| County: |
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| Country: |
JA |
| Establishment Operation Code(s): |
MS - Specification Developer
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| Establishment Status Code: |
A -
Active
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Year of Most Recent Initial or Annual Registration: |
2007 |
| FDA-Supplied Owner/Operator Information: |
| Owner/Operator Number: |
9067818 |
| Company Name: |
OLYMPUS MEDICAL SYSTEMS CORPORATION
|
| Address: |
2951 ISHIKAWA-CHO |
| Address 2: |
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| City: |
HACHIOJI-SHI, TOKYO |
| State: |
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| Zip / Postal Code: |
192-8507 |
| Country: |
JA |
| Owner/Operator Phone: |
--
|
| FDA-Supplied Official Correspondent Information: |
| Official Correspondent Name: |
MS. LAURA STORMS-TYLER |
| Company Name: |
OLYMPUS AMERICA, INC. |
| Address: |
3500 CORPORATE PARKWAY |
| Address 2: |
P.O. BOX 610 |
| City: |
CENTER VALLEY |
| State: |
PA |
| Zip / Postal Code: |
18034 0610 |
| Country: |
US |
| Official Corespondent Phone Number: |
484-896-5688
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| FDA-Supplied US Agent Information: |
| US Agent Contact Name / Title: |
MS. LAURA STORMS-TYLER , DIRECTOR REGULATORA AFFAIRS & QUALITY ASSURANCE |
| Company Name: |
OLYMPUS AMERICA, INC. |
| Address: |
3500 CORPORATE PKWY. |
| Address 2: |
P.O. BOX 610 |
| City: |
CENTER VALLEY |
| State: |
PA |
| Zip Code: |
18034 0610 |
| Country: |
US |
| US Agent Phone Number: |
484-896-5688 |
| US Agent Email Address: |
LAURA.STORMS-TYLER@OLYMPUS.COM
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| Other Establishment Information: |
| Establishment Phone: |
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| Fax: |
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| General Email: |
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| Web Site: |
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| Company Brochure: |
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| Keywords: |
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| Company Description: |
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| Services Offered: |
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| About Us: |
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| Differentiation: |
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FDA-Registered Products Offered by OLYMPUS MEDICAL SYSTEMS CORPORATION
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Common Device Name |
Proprietary Device Name |
| 1 |
ANGIOSCOPES, LIGHT SOURCES, VALVULOTOMES, AND ACCESSORIES |
OLYMPUS ANGIOSCOPES & ACCESSORIES |
| 2 |
BIOPSY FORCEPS |
BIOPSY FORCEPS |
| 3 |
CAMERA, ENDOSCOPES, LIGHT SOURCES, CABLES, VIDEO ACCESORIES |
CAMERA, SURGICAL AND ACCESSORIES (MULTIPLE BRANDS) |
| 4 |
CHOLEDOCHOSCOPES & ACCESSORIES |
CHOLEDOCHOSCOPE, FLEXIBLE OR RIGID (MULTIPLE BRANDS) |
| 5 |
CYSTOSCOPES AND NEPHROSCOPES |
CYSTOSCOPES AND NEPHROSCOPES |
| 6 |
ELECTROSURGICAL, CUTTING & COAGULATION DEVICES |
SONOSURG, PSD-60, ENDO PLASMA |
| 7 |
ENDOSCOPE |
ENDOSCOPE |
| 8 |
ENDOSCOPE & ACCESSORIES |
LECTURESCOPE |
| 9 |
ENDOSCOPE CONTOUR DETECTION SYSTEM |
ENDOSCOPE CONTOUR DETECTION SYSTEM |
| 10 |
ENDOSCOPIC CLIPPING DEVICES |
ENDOSCOPIC CLIPPING DEVICES |
| 11 |
ENDOSCOPIC ULTRASOUND SYSTEM |
ENDOSCOPIC ULTRASOUND SYSTEM |
| 12 |
ENDOSCOPIC ULTRASOUND SYSTEM |
ENDOSCOPIC ULTRASOUND SYSTEM |
| 13 |
ENDOSCOPY IMAGING SYSTEM |
EVIS EXERA ENDOSCOPY SYSTEM |
| 14 |
GRASPING FORCEPS |
GRASPING FORCEPS |
| 15 |
LAPARO-THORACO VIDEOSCOPE |
LAPARO-THORACO VIDEOSCOPE |
| 16 |
LAPAROSCOPES AND ACCESSORIES |
LAPAROSCOPIC SURGICAL PRODUCTS & ACCESSORIES |
| 17 |
LAPAROSCOPIC & ACCESSORIES |
LAPAROSCOPIC & ACCESSORIES (MULTIPLE BRANDS) |
| 18 |
LUS ULTRASONIC LITHOTRIPTOR |
LUS ULTRASONIC LITHOTRIPTOR |
| 19 |
MECHANICAL LITHOTRIPTOR |
MECHANICAL LITHOTRIPTOR |
| 20 |
OROTRACHEAL INTUBATION ENDOSCOPE |
OROTRACHEAL INTUBATION ENDOSCOPE |
| 21 |
SMALL INTESTINE ENDOSCOPE |
SMALL INTESTINE ENDOSCOPE |
| 22 |
SURGICAL OPERATING MICROSCOPE |
OME 8000, 8000 NEUROPLUS |
| 23 |
ULTRASONIC SURGICAL INSTRUMENT |
SONOSURG |
| 24 |
ULTRASONIC SURGICAL SYSTEM |
ULTRASONIC SURGICAL SYSTEM |
| 25 |
VARIOUS MODELS OF BRONCHOSCOPES |
BRONCHOSCOPE (FLEXIBLE OR RIGID)- MULTIPLE BRANDS |
| 26 |
VARIOUS MODELS OF COLPOSCOPES & ACCESSORIES |
COLPOSCOPE (AND COLPOMICROSCOPE) - MULTIPLE BRANDS |
| 27 |
VARIOUS MODELS OF ELECTROSURGICAL UNITS |
MULTIPLE PRODUCT NAMES |
| 28 |
VARIOUS MODELS OF ENDOSCOPES & ACCESSORIES |
GASTROSCOPE, GASTRO-UROLOGY (MULTIPLE BRANDS) |
| 29 |
VARIOUS MODELS OF ENDOSCOPES & ACCESSORIES |
SIGMOIDOSCOPE, FLEXIBLE (MULTIPLE BRANDS) |
| 30 |
VARIOUS MODELS OF ENDOSCOPES & ACCESSORIES |
COLONOSCOPE, GASTRO-UROLOGY (MULTIPLE BRANDS) |
| 31 |
VARIOUS MODELS OF ENDOSCOPES & ACCESSORIES |
ENDOALPHA |
| 32 |
VARIOUS MODELS OF ENDOSCOPES AND ACCESSORIES |
DUODEDOSCOPE, ESOPHAGO GASTRO (MULTIPLE BRANDS) |
| 33 |
VARIOUS MODELS OF HYSTEROFIBERSCOPES & ACCESSORIES |
HYSTEROSCOPE (AND ACCESSORIES) (MULTIPLE BRANDS) |
| 34 |
VARIOUS MODELS OF LAPAROSCOPES & ACCESSORIES |
3D LAPAROSCOPE |
| 35 |
VARIOUS MODELS OF LAPAROSCOPES & ACCESSORIES |
INSUFFLATOR, LAPAROSCOPIC (MULTIPLE BRANDS) |
| 36 |
VARIOUS MODELS OF LARYNGOSCOPES |
LARYNGOSCOPES |
| 37 |
VARIOUS MODELS OF NASOPHARYHGOSCOPES |
NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) - MULTIPLE BRANDS |
| 38 |
VARIOUS MODELS OF NEUROLOGICAL ENDOSCOPES |
NEEDLESCOPE |
| 39 |
VARIOUS MODELS OF RHINOLARYNOLARYNOSCOPES & ACCESSORIES |
LARYNGOSCOPE, ENDOSCOPE (MULTIPLE BRANDS) |
| 40 |
VARIOUS MODELS OF ULTRASOUND SYSTEMS, ENDOSCOPES & ACCESSORIES |
ENDOSCOPIC ULTRASOUND SYSTEM (MULTIPLE BRANDS) |
| 41 |
VARIOUS MODELS OF URETERORENOFIBERSCOPES, CYSTOFIBERSCOPES & NEPHHROFIBERSCOPE |
ENDOSCOPE, FLEXIBLE (MULTIPLE BRANDS) |
| 42 |
VARIOUS MODELS OF VIDEO EQUIPMENT & ACCESSORIES |
VIDEO EQUIPMENT & ACCESSORIES (MULTIPLE BRANDS) |
| 43 |
VARIOUS TYPES OF ASPIRATION & INJECTION NEEDLES |
SET, BIOPSY NEEDLE AND NEEDLE, GASTRO-UROLOGY (MULTIPLE BRANDS) |
| 44 |
VARIOUS TYPES OF ASPIRATION AND INJECTION NEEDLES |
MULTIPLE PRODUCT NAMES |
| 45 |
VARIOUS TYPES OF BD BRUSHES |
PANCREATIC/BILIARY BRUSHES |
| 46 |
VARIOUS TYPES OF CANNULAS |
CANNULAS |
| 47 |
VARIOUS TYPES OF COAGULATION ELECTRODES |
CD COAGULATION ELECTRODES |
| 48 |
VARIOUS TYPES OF ENDOSCOPIC CLIPS & LIGATION DEVICES |
HX-5/6, HX-20 |
| 49 |
VARIOUS TYPES OF ENDOTHERAPY PRODUCTS - HOT BIOPSY FORCEPS |
FORCEPS, BIOPSY, ELECTRIC (MULTIPLE BRANDS) |
| 50 |
VARIOUS TYPES OF LARYNGOSCOPES |
NO PROPRIETARY NAME LISTED |
| 51 |
VARIOUS TYPES OF SNARES |
SD SERIES OF SNARES |
| 52 |
VARIOUS TYPES OF VALVUTOMES |
VALVULOTOME |
| All FDA-Registered products for this company are displayed above. |