FDA 510(k) Applications for Medical Device:
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K981827 | ANGIOLAZ, INC. |
P.O. BOX 556 | BELLOWS FALLS | VT | 05101 |
| K962024 | DEL MEDICAL SYSTEMS CORP. |
ONE COMMERCE PARK | VALHALLA | NY | 10595 |
| K192286 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K243260 | Fujifilm Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K150221 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
10 HIGH POINT DRIVE | WAYNE | NJ | 07470 |
| K163675 | FUJIFILM Medical System U.S.A., Inc. |
10 High Point Drive | Wayne | NJ | 07470 |
| K180414 | FUJIFILM New Development U.S.A., Inc. |
318 Bear Hill Road | Waltham | MA | 02451 |
| K102466 | FUJINON, INC. |
80 SHELTON TECHNOLOGY CENTER | SHELTON | CT | 06484 |
| K012660 | GIMMI GMBH |
AMSTEL 320-I | AMSTERDAM | 1017AP | |
| K981856 | GREATBATCH SCIENTIFIC |
9645 WEHRLE DR. | CLARENCE | NY | 14031-1899 |
| K243321 | Guangzhou Red Pine Medical Instrument Co., Ltd. |
12 F, No.87 Luoxuan Avenue | Guangzhou | 510000 | |
| K013709 | HILL-ROM, INC. |
1069 STATE RT. 46 EAST | BATESVILLE | IN | 47006 |
| K080809 | INNOVATIVE ENDOSCOPY COMPONENTS, LLC. |
731-733 SHOTGUN RD. | FT. LAUDERDALE | FL | 33326 |
| K992469 | KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K221174 | KARL STORZ Endoscopy America, Inc |
2151 E. Grand Avenue | El Segundo | CA | 90245 |
| K160044 | KARL STORZ ENDOSCOPY AMERICA, INC. |
2151 E. GRAND AVE | EL SEGUNDO | CA | 90245 |
| K193235 | Karl Storz Endoscopy America, Inc. |
2151 E. Grand Ave | El Segundo | CA | 90245 |
| K182696 | KARL STORZ Endoscopy-America, Inc |
2151 E. Grand Ave | EI Segundo | CA | 90245 |
| K043324 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K070716 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K111997 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVE. | EL SEGUNDO | CA | 90245 |
| K201135 | Karl Storz Endoscopy-America, Inc. |
2151 E. Grand Avenue | El Segundo | CA | 90245 |
| K131953 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVENUE | EL SEGUNDO | CA | 90245 |
| K031895 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K994348 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K003113 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K994090 | KARL STORZ IMAGING, INC. |
175 CREMONA DR. | GOLETA | CA | 93117 |
| K973252 | KARL STORZ IMAGING, INC. |
175 CREMONA DR. | GOLETA | CA | 93117 |
| K003325 | KARL STORZ IMAGING, INC. |
175 CREMONA DR. | GOLETA | CA | 93117 |
| K032545 | MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) |
SCHWARZSCHILDSTRASSE 6 | BERLIN | 12489 | |
| K032544 | MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) |
SCHWARZSCHILDSTRASSE 6 | BERLIN | 12489 | |
| K954451 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K971416 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K041494 | OLYMPUS CORPORATION |
TWO CORPORATE CENTER DRIVE | MELVILLE | NY | 11747-3157 |
| K242067 | Olympus Corporations of the Americas |
800 West Park Drive | Westborough | MA | 01581 |
| K172817 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K201200 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K202646 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K190449 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K102059 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWY | CENTER VALLEY | PA | 18034-0610 |
| K222584 | Olympus Medical Systems Corporation |
2951 Ishikawa-cho | Tokyo | ||
| K083155 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K241371 | Olympus Medical Systems Corporation |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K113873 | PENTAX OF AMERICA, INC. |
1129 BLOOMFIELD AVENUE | WEST CALDWELL | NJ | 07006 |
| K023659 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K964173 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K130423 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K211332 | Richard Wolf Medical Instruments Corporation |
353 Corporate Woods Parkway | Vernon Hills | IL | 60061 |
| K161204 | RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION |
353 CORPORATE WOODS PARKWAY | VERNON HILL | IL | 60061 |
| K180583 | Richard Wolf Medical Instruments Corporation |
353 Corporate Woods Parkway | Vernon Hills | IL | 60061 |
| K200617 | Richard Wolf Medical Instruments Corporation |
353 Corporate Woods Parkway | Vernon Hills | IL | 60061 |
| K212808 | Richard Wolf Medical Instruments Corporation |
353 Corporate Woods Parkway | Vernon Hills | IL | 60061 |
| K992362 | SCHOELLY FIBEROPTIC, GMBH |
45 PONTIAC RD. | NEWTON | MA | 02248 |
| K090800 | SCHOELLY IMAGING, INC. |
100 INDIAN HEAD ROAD | FRAMINGHAM | MA | 01701 |
| K241532 | Shanghai SeeGen Photoelectric Technology Co., Ltd. |
3 Floor, Building No.1, 4299 JinDu Road, | Shanghai | 201108 | |
| K250204 | Shenzhen Sophway Technology Co., Ltd. |
A1301A,Bldg 1,Meixun Digital Technology Factory,No. 19Jinxiu | Shenzhen | 518122 | |
| K003710 | SMITH & NEPHEW, INC. |
160 DASCOMB RD. | ANDOVER | MA | 01810 |
| K972540 | SOPRO |
PLACE ST. CHRISTOPHE | MARSEILLE | 13011 | |
| K973798 | SOPRO |
PLACE ST. CHRISTOPHE | MARSEILLE | 13011 | |
| K102949 | STI MEDICAL SYSTEMS, LLC |
99-193 AIEA HEIGHTS DRIVE | AIEA | HI | 96701 |
| K081585 | VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS |
10 GREENLAWN AVE | SOUTH GRAFTON | MA | 01560 |
| K020301 | VISTA MEDICAL TECHNOLOGIES, INC. |
134 FLANDERS RD. | WESTBOROUGH | MA | 01581 |
| K971373 | VISTA MEDICAL TECHNOLOGIES, INC. |
134 FLANDERS RD. | WESTBOROUGH | MA | 01581 |
| K152109 | W.O.M. WORLD OF MEDICINE GmbH |
Salzufer 8 | Berlin | 10587 | |
| K190648 | Zhuhai Pusen Medical Technology Co., Ltd. |
5/F, Building 1, No 33, Keji San Road, High-tech Zone | Tangjiawan Town | 519085 |
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