FDA 510(k) Applications for Medical Device:
Kit, Needle, Biopsy
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K062979 | ACD MEDICAL INNOVATION CORP. |
13 RED FOX LANE | LITTLETON | CO | 80127 |
| K024120 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD. MPWM-1E | MCGAW PARK | IL | 60085 |
| K181756 | AprioMed AB |
Virdings Alle 28 | Uppsala | 75450 | |
| K983218 | AVID N.I.T., INC. |
390 SCARLET BLVD. | OLDSMAR | FL | 34677 |
| K081323 | B-K MEDICAL APS |
MILEPARKEN 34 | HERLEV | DK-2730 | |
| K133008 | BEACON ENDOSCOPIC |
2000 COMMONWEALTH AVE STE 110 | AUBURNDALE | MA | 02466 |
| K212423 | Bibbinstruments AB |
Scheelevagen 2 | Lund | S-223 63 | |
| K050135 | BIOENGINEERING CONSULTANTS LTD. |
801 WEST MAIN STREET | CHARLOTTESVILLE | VA | 22903 |
| K021847 | BIOPSY SCIENCES, LLC |
5582 CHALON RD. | YORBA LINDA | CA | 92886 |
| K011075 | BIOPSYBELL S.A.S. |
131 HIGHWOOD DR. | SOUTH GLASTONBURY | CT | 06073 |
| K103668 | BOSTON ENDOSCOPIC ENGINEERING |
53 KENNEDY ROAD | FOSTER | RI | 02825 |
| K040893 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K050120 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K012864 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PLACE | NATICK | MA | 01760-1537 |
| K151895 | BOSTON SCIENTIFIC CORPORATION |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K100712 | Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K171956 | Changzhou Detain Medical Devices Co., Ltd. |
No.47, North Qingyang Rd, Tianning District | Changzhou | 213017 | |
| K083330 | COOK ENDOSCOPY |
4900 BETHANIA STATION RD. & | WINSTON-SALEM | NC | 27105 |
| K092359 | COOK IRELAND LTD |
O'HALLORAN ROAD | LIMERICK | ||
| K142688 | COOK IRELAND LTD |
O'HALLORAN ROAD | LIMERICK | ||
| K093195 | COOK IRELAND LTD |
O'HALLORAN ROAD | LIMERICK | ||
| K241209 | Cook Ireland Ltd. |
O'Halloran Road | Limerick | V94 N8X2 | |
| K160229 | Cook Ireland Ltd. |
O' Halloran Road, National Technology Park, | Limerick | ||
| K210476 | Cook Ireland Ltd. |
O'Halloran Road, National Technology Park | Limerick | V94N8X2 | |
| K230909 | Cook Ireland Ltd. |
O'Halloran Road | Limerick | V94 N8X2 | |
| K963565 | COOK, INC. |
925 SOUTH CURRY PIKE | BLOOMINGTON | IN | 47402 |
| K160423 | Corbin Clinical Resources, LLC |
12234 Williams Road | Cumberland | MD | 21502 |
| K180037 | Covidien llc |
15 Hampshire Street | Mansfield | MA | 02048 |
| K141894 | COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP) |
2000 COMMONWEALTH AVE. SUITE 110 | AUBURNDALE | MA | 02466-2008 |
| K150891 | Covidien LLC( Formerly Beacon Endoscopic Corp.) |
15 Hamshire Street | Mansfield | MA | 02048 |
| K073399 | ENVISIONEERING, LLC. |
1982 INNERBELT BUSINESS CTR DR | ST. LOUIS | MO | 63114 |
| K961185 | FERGUSON MEDICAL |
3407 BAY AVE. | CHICO | CA | 95973-8619 |
| K963894 | FERGUSON MEDICAL |
3407 BAY AVE. | CHICO | CA | 95973-8619 |
| K180363 | Finemedix Co. Ltd. |
60, Maeyeo-ro, Dong-gu | Daegu | 41065 | |
| K231267 | Finemedix Co., Ltd. |
140-9, Yuram-ro, Dong-gu | Daegu | 41059 | |
| K962568 | GALLINI INTL., INC. |
1454 ROCKAWAY PKWY., SUITE 300 | BROOKLYN | NY | 11236 |
| K962569 | GALLINI INTL., INC. |
1454 ROCKAWAY PKWY., SUITE 300 | BROOKLYN | NY | 11236 |
| K962570 | GALLINI INTL., INC. |
1454 ROCKAWAY PKWY., SUITE 300 | BROOKLYN | NY | 11236 |
| K962905 | GALLINI S.R.L. |
1454 ROCKAWAY PKWY. | BROOKLYN | NY | 11236 |
| K002947 | H.S. HOSPITAL SERVICE S.R.L. |
131 HIGHWAY DR. | SOUTH GLASTONBURY | CT | 06073 |
| K002944 | H.S. HOSPITAL SERVICE S.R.L. |
131 HIGHWAY DR. | SOUTH GLASTONBURY | CT | 06073 |
| K002946 | H.S. HOSPITAL SERVICE S.R.L. |
131 HIGHWAY DR. | SOUTH GLASTONBURY | CT | 06073 |
| K021525 | H.S. HOSPITAL SERVICE S.R.L. |
10147 UMBERLAND PLACE | BOCA RATON | FL | 33428 |
| K013069 | H.S. HOSPITAL SERVICES S.P.A. |
10147 UMBERLAND PLACE | BOCA RATON | FL | 33428 |
| K131925 | H.S. HOSPITAL SERVICES S.P.A. |
10147 UMBERLAND PLACE | BOCA RATON | FL | 33428 |
| K013070 | H.S. HOSPITAL SERVICES S.P.A. |
10147 UMBERLAND PLACE | BOCA RATON | FL | 33428 |
| K013071 | H.S. HOSPITAL SERVICES S.P.A. |
10147 UMBERLAND PLACE | BOCA RATON | FL | 33428 |
| K013109 | HAKKO MEDICAL CO., LTD. |
7-9 KAMIMEGURO 1-CHOME | MEGURO-KU, TOKYO | 153 | |
| K012358 | ISPG, INC. |
517 LITCHFIELD RD. | NEW MILFORD | CT | 06776 |
| K960317 | LAURUS MEDICAL CORP. |
30 HUGHES | IRVINE | CA | 92718 |
| K231422 | Limaca Medical Ltd |
3 Ha'Rimon street | En Ha'Emeq | 1925000 | |
| K990220 | MEDI-GLOBE CORP. |
6202 SOUTH MAPLE AVE. # 131 | TEMPE | AZ | 85283 |
| K051247 | MEDI-GLOBE CORP. |
110 WEST ORION, SUITE 136 | TEMPE | AZ | 85283 |
| K091257 | MEDI-GLOBE CORPORATION |
110 WEST ORION ST #136 | TEMPE | AZ | 85283 |
| K083802 | MEDI-GLOBE CORPORATION |
110 WEST ORION ST #136 | TEMPE | AZ | 85283 |
| K070129 | MEDI-GLOBE CORPORATION |
110 WEST ORION #136 | TEMPE | AZ | 85283 |
| K133763 | MEDI-GLOBE CORPORATION |
110 WEST ORION STREET | TEMPE | AZ | 85283 |
| K151373 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K970563 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K991672 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K151738 | OLYMPUS MEDICAL SYSTEMS CORP. |
2951 ISHIKAWA-CHO | HACHIOJI-SHI | 192-8507 | |
| K180449 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-Shi | 192-8507 | |
| K181994 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-Shi | 192-8507 | |
| K160098 | OLYMPUS MEDICAL SYSTEMS CORP. |
2951 ISHIKAWA-CHO | HACHIOJI-SHI | 192-8507 | |
| K180668 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K050503 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-9058 |
| K070179 | PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL-STRASSE 1 | GEISINGEN, BADEN-WURTTEMBERG | 78187 | |
| K140137 | PFM MEDICAL, INC |
1815 ASTON AVE, SUITE 106 | CARLSBAD | CA | 92008 |
| K011270 | PROMEX, INC. |
3049 HUDSON ST. | FRANKLIN | IN | 46131 |
| K051506 | STERYLAB S.R.L. |
6329 W. WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K212819 | Suzhou Leapmed Healthcare Corporation |
Wuzhong Science Park, NO.2 & NO.3 Building | Suzhou | 215100 | |
| K212822 | Suzhou Leapmed Healthcare Corporation |
Wuzhong Science Park, NO.2 & NO.3 Building | Suzhou | 215100 | |
| K023272 | THE OLYMPUS OPTICAL CO. |
TWO CORPORATE DR. | MELVILLE | NY | 11747 |
| K971842 | UNITED STATES ENDOSCOPY GROUP, INC. |
9330 PROGRESS PKWY. | MENTOR | OH | 44060 |
| K103694 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K191472 | Ushare Medical Inc. |
445 An Ji Zhong Road, San Zao Town | Zhuhai | 519090 | |
| K171596 | Wilson-Cook Medical Inc. |
4900 Bethania Station Road | Winston-Salem | NC | 27105 |
| K160890 | WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION ROAD | WINSTON-SALEM | NC | 27105 |
| K961897 | WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. | WINSTON-SALEM | NC | 27105 |
| K013356 | WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. | WINSTON-SALEM | NC | 27105 |
| K981889 | WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
125 MAIN ST., NORTH | WOODBURY | CT | 06798-0505 |
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