FDA 510(k) Applications for Medical Device:
Bronchoscope (Flexible Or Rigid)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K130845 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K161656 | AMBU A/S |
BALTORPBAKKEN 13 | BALLERUP | DK-2750 | |
| K173727 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K223782 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K220606 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K230428 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K232582 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K223299 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K210883 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K202987 | Anrei Medical (Hangzhou) Co., Ltd |
No. 3 Ave 8, HEDA | Hangzhou | 310018 | |
| K022446 | AOMORI OLYMPUS CO., LTD. |
2 CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K211493 | Auris Health, Inc. |
150 Shoreline Drive | Redwood | CA | 94065 |
| K193534 | Auris Health, Inc. |
150 Shoreline Drive | Redwood City | CA | 94065 |
| K152319 | AURIS SURGICAL ROBOTICS, INC. |
125 SHOREWAY ROAD, SUITE D | SAN CARLOS | CA | 94070 |
| K173760 | Auris Surgical Robotics, Inc. |
125 Shoreway Road | San Carlos | CA | 94070 |
| K212886 | Axess Vision Technology |
Zone de la LiodiΦre 6, rue de la FlottiΦre | JouΘ-lΦs-Tours | 37300 | |
| K202180 | Axess Vision Technology |
Zone de la LiodiΦre 6, rue de la FlottiΦre | JouΘ-lΦs-Tours | 37300 | |
| K024165 | BISTECH, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K172955 | Body Vision Medical Ltd. |
34 SOKOLOV ST. | Ramat Hasharon | ||
| K040018 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K963252 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K183085 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K222014 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K211030 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K151315 | BOSTON SCIENTIFIC CORPORATION |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K163248 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K221340 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K131234 | BRONCUS MEDICAL INC |
1400 N. Shoreline Blvd., Bldg A, Suite 8 | Mountain View | CA | 94043 |
| K200702 | Broncus Medical, Inc |
125 Nicholson Lane | San Jose | CA | 95134 |
| K980046 | BRONCUS TECHNOLOGIES, INC. |
1400N SHORELINE BLVD. | MOUNTAIN VIEW | CA | 94043 |
| K993900 | BRONCUS TECHNOLOGIES, INC. |
1400N SHORELINE BLVD. | MOUNTAIN VIEW | CA | 94043 |
| K013111 | BRONCUS TECHNOLOGIES, INC. |
1400 NORTH SHORELINE BLVD., | MOUNTAIN VIEW | CA | 94043-1346 |
| K011267 | BRONCUS TECHNOLOGIES, INC. |
1400N SHORELINE BLVD. | MOUNTAIN VIEW | CA | 94043 |
| K090853 | BRONCUS TECHNOLOGIES, INC. |
1400 N. SHORELINE BLVD. BLDG A | MOUNTAIN VEIW | CA | 94043 |
| K091250 | CARDINAL HEALTH, INC. |
1430 WAUKEGAN ROAD- MPKB-3B | MCGAW PARK | IL | 60085 |
| K031966 | COOK, INC. |
750 DANIELS WAY | BLOOMINGTON | IN | 47402-0489 |
| K142934 | COVIDIEN |
161 Cheshire Lane Suite 100 | Plymouth | MN | 55441 |
| K163537 | Covidien llc |
161 Cheshire Lane, Suite 100 | Plymouth | MN | 55441 |
| K142839 | Covidien LLC |
161 Cheshire Lane, Suite 100 | Plymouth | MN | 55441 |
| K983878 | E. BENSON HOOD LABORATORIES, INC. |
575 WASHINGTON ST. | PEMBROKE | MA | 02359 |
| K183607 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K182825 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K182253 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K220957 | FUJIFILM Corporaton |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K122535 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
10 HIGH POINT DRIVE | WAYNE | NJ | 07470 |
| K121035 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
10 HIGH POINT DRIVE | WAYNE | NJ | 07470 |
| K171291 | FUJIFILM Medical Systems U.S.A., Inc. |
10 High Point Drive | Wayne | NJ | 07470 |
| K050907 | FUJINON, INC. |
543 LONG HILL AVENUE | SHELTON | CT | 06484 |
| K013731 | GIMMI GMBH |
AMSTEL 320-I | AMSTERDAM | 1017AP | |
| K022546 | HORIZONS INTL. CORP. |
287 MONTERREY ST. | PONCE | PR | 00717 |
| K191828 | Hunan Vathin Medical Instrument Co., Ltd. |
1/F, Building 12, No 9 Chuanqi west road, | Xiangtan | 411100 | |
| K213635 | Hunan Vathin Medical Instrument Co., Ltd. |
1/F, Building 12, No.9 Chuanqi West Road, Jiuhua Economic | Xiangtan | 411100 | |
| K223836 | Hunan Vathin Medical Instrument Co., Ltd. |
1/F, Building 12, Innovation and Entrepreneurship Service | Xiangtan | 411100 | |
| K182188 | Intuitive Surgical |
1266 Kifer Road | Sunnyvale | CA | 94086 |
| K192367 | Intuitive Surgical, Inc. |
1266 Kifer Rd. | Sunnyvale | CA | 94086 |
| K201146 | Intuitive Surgical, Inc. |
1266 Kifer Rd. | Sunnyvale | CA | 94086 |
| K202370 | Intuitive Surgical, Inc. |
1266 Kifer Road | Sunnyvale | CA | 94086 |
| K220299 | Intuitive Surgical, Inc. |
1266 Kifer Road | Sunnyvale | CA | 94086 |
| K212048 | Intuitive Surgical, Inc. |
1266 Kifer Road | Sunnyvale | CA | 94086 |
| K212656 | KARL STORZ Endoscopy America |
2151 E. Grand Avenue | El Segundo | CA | 90245 |
| K960791 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K961178 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K954797 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K071530 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K982983 | LSVP INTL., INC. |
12755 ALTO VERDE LN. | LOS ALTOS HILLS | CA | 94022 |
| K131401 | MERCATOR MEDSYSTEMS, INC. |
1670 ALVARADO SUITE #4 | SAN LEANDRO | CA | 94577 |
| K213782 | Micro-Tech (Nanjing) Co., Lts |
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial | Nanjing | 210032 | |
| K960880 | MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. | MENTOR | OH | 44060-4885 |
| K983122 | MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. | MENTOR | OH | 44060-4885 |
| K983124 | MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. | MENTOR | OH | 44060-4885 |
| K962736 | MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. | MENTOR | OH | 44060-4885 |
| K223144 | Noah Medical Corp. |
1501 Industrial Rd. | San Carlos | CA | 94070 |
| K963033 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K962901 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K962367 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K962380 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K962555 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K962485 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K962378 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K962533 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K040940 | OLYMPUS CORPORATION |
TWO CORPORATE CENTER DRIVE | MELVILLE | NY | 11747-3157 |
| K201300 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-Shi | 192-8507 | |
| K172726 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-Shi | 192-8507 | |
| K201758 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-Shi | 192-8507 | |
| K183419 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-Shi | 192-8507 | |
| K121959 | OLYMPUS MEDICAL SYSTEMS CORP. |
3500 CORPORATE PARKWAY | CENTER VALLY | PA | 18034 |
| K200397 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K200342 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K192164 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K212667 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K221631 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Tokyo | 192-8507 | |
| K061313 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K050220 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-9058 |
| K222861 | Olympus Medical Systems Corporation |
2951 Ishikawa-cho | Tokyo | 192-8507 | |
| K060243 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-9058 |
| K082720 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K033225 | OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K220399 | OTU Medical Inc. |
2231 A Fortune Drive | San Jose | CA | 95131 |
| K131946 | PENTAX MEDICAL COMPANY |
3 Paragon Drive | MONTVALE | NJ | 07645-1782 |
| K131028 | PENTAX MEDICAL COMPANY |
3 PARAGON DRIVE | MONTVALE | NJ | 07645 |
| K081518 | PENTAX MEDICAL COMPANY |
102 CHESTNUT RIDGE RD. | MONTVALE | NJ | 07645-1856 |
| K183654 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K143727 | PENTAX OF AMERICA, INC. |
3 PARAGON DRIVE | MONTVALE | NJ | 07645 |
| K213235 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K183516 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K200678 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K210928 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K173554 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K023376 | PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. | ORANGEBURG | NY | 10962 |
| K990547 | PILLING WECK, INC. |
1 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K974642 | PLASTIMED LABORATOIRE PHARMACEUTIQUE |
212 3RD AVENUE NORTH | MINNEAPOLIS | MN | 55401 |
| K152466 | PROSURG, INC |
2193 Trade Zone Blvd | San Jose | CA | 95131 |
| K150280 | SANOVAS, INC. |
2597 Kerner Blvd | San Rafael | CA | 94901 |
| K141366 | SCHOLLY FIBEROPTIC GMBH |
ROBERT-BOSCH-STR. 1-3 | DENZLINGEN | D-79211 | |
| K210379 | Scivita Medical Technology Co., Ltd. |
No.8, ZhongTian Xiang, Suzhou Industrial Park | Suzhou | 215000 | |
| K221302 | Serpex Medical, Inc. |
3350 Scott Blvd, Suite 37B | Santa Clara | CA | 95054 |
| K211169 | Shanghai AnQing Medical Instrument CO., Ltd. |
3&4 Floor, No. 2 Building, 366 Huiqing Road, Zhangjiang | Shanghai | 201201 | |
| K222910 | Shenzhen HugeMed Medical Technical Development Co., Ltd |
416-1, 516-1, Building 2, No. 1, Mawu Road, Baoan | Shenzhen | 518100 | |
| K171492 | Spiration, Inc. |
6675 185th Avenue N.E. | Redmond | WA | 98052 |
| K142909 | SPIRATION, INC. |
6675 185TH AVENUE NE | REDMOND | WA | 98052 |
| K162611 | SPIRATION, INC. |
6675 185TH AVE NE | REDMOND | WA | 98052 |
| K071473 | SUPERDIMENSION, LTD. |
555 ZANG STREET | LAKEWOOD | CO | 80228 |
| K023984 | THE OLYMPUS OPTICAL CO. |
TWO CORPORATE DR. | MELVILLE | NY | 11747 |
| K981543 | THE OLYMPUS OPTICAL CO. |
ENDOSCOPE DIVISION | MELVILLE | NY | 11747-3157 |
| K012073 | THE OLYMPUS OPTICAL CO. |
TWO CORPORATE DR. | MELVILLE | NY | 11747 |
| K970107 | UROHEALTH SYSTEMS, INC. |
3050 REDHILL AVE. | COSTA MESA | CA | 92626 |
| K202346 | Veran Medical Technologies, Inc. |
1908 Innerbelt Business Center Dr | St. Louis | MO | 63114 |
| K230948 | Verathon Medical (Canada) ULC |
2227 Douglas Road | Burnaby | V5C 5A9 | |
| K211947 | Verathon Medical (Canada) ULC |
2227 Douglas Road | Burnaby | V5C 5A9 | |
| K193488 | Verathon Medical (Canada) ULC |
2227 Douglas Road | Burnaby | V5C 5A9 | |
| K191948 | Verathon Medical (Canada) ULC |
2227 Douglas Road | Burnaby | V5C 5A9 | |
| K183256 | Verathon Medical (Canada) ULC |
2227 Douglas Road | Burnaby | V3W 1P2 | |
| K021344 | VISION-SCIENCES, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K091768 | VISION-SCIENCES, INC. |
40 RAMLAND RD. SOUTH | ORANGEBURG | NY | 10962 |
| K963795 | VISION-SCIENCES, INC. |
6 STRATHMORE RD. | NATICK | MA | 01760 |
| K163377 | Wilson-Cook Medical Inc. |
4900 Bethania Station Road | Winstom-Salem | NC | 27105 |
| K984157 | WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. | WINSTON-SALEM | NC | 27105 |
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