FDA 510(k) Applications for Medical Device:
Stent, Ureteral
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K190659 | Allwin Medical Devices, Inc. |
3305 E. Mira Loma Avenue, Suite 176 | Anaheim | CA | 92806 |
| K243039 | Alton (Shanghai) Medical Instruments Co. Ltd |
No.24 Building Jinshao Rd 1688.Baoshan District. | Shanghai | 200949 | |
| K991219 | APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE | LAGUNA HILLS | CA | 92653 |
| K011264 | APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa | Rancho Santa Margarita | CA | 92688 |
| K040760 | APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa | Rancho Santa Margarita | CA | 92688 |
| K060673 | APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa | Rancho Santa Margarita | CA | 92688 |
| K033210 | BIOTEQUE CORP. |
3892 SOUTH AMERICA WEST TRAIL | FLAGGSTAFF | AZ | 86001 |
| K010002 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K141344 | BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K030503 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K974541 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K013784 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K211934 | Boston Scientific Corporation |
One Scimed Place | Maple Grove | MN | 55311 |
| K200260 | Boston Scientific Corporation |
Three Scimed Place | Maple Grove | MN | 55311 |
| K250824 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K163399 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K190603 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K191609 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K191446 | Boston Scientific Corporation |
300 Boston Scientific Way | Marlborough | MA | 01752 |
| K161277 | BRIGHTWATER MEDICAL |
816 W. BENNETT CT. | DUNLAP | IL | 61525 |
| K022447 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K983498 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K043193 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD | COVINGTON | GA | 30014 |
| K960148 | CABOT MEDICAL CORP. |
2021 CABOT BOULEVARD WEST | LANGHORNE | PA | 19047 |
| K170422 | Coloplast Corp |
1601 West River Road north | Minneapolis | MN | 55411 |
| K213185 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55411 |
| K180469 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55411 |
| K213186 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55411 |
| K170362 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55411 |
| K201436 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55411 |
| K180057 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55411 |
| K181971 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K172017 | Cook Incorporated |
750 Daniels Way P.O. Box 489 | Bloomington | IN | 47402 |
| K162104 | COOK INCORPORATED |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K171603 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47402 |
| K180557 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K162109 | COOK INCORPORATED |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K180029 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K170010 | COOK INCORPORATED |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K180216 | Cook Incorporated |
750 Daniels Way P.O. Box 489 | Bloomington | IN | 47402 |
| K180053 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K160891 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K161236 | COOK INCORPORATED |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K151051 | COOK INCORPORATED |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K063742 | COOK IRELAND LTD |
O'HALLORAN ROAD | LIMERICK | ||
| K961446 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K952513 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K961371 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K190312 | Dornier MedTech America Inc. |
1155 Roberts Blvd, Suite 100 | Kennesaw | GA | 30144 |
| K021140 | FOSSA INDUSTRIES, INC. |
580 HARRISON AVE., | BOSTON | MA | 02118 |
| K021602 | FOSSA INDUSTRIES, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K072293 | FOSSA MEDICAL, INC. |
50 REDFIELD STREET | BOSTON | MA | 02122 |
| K031292 | FOSSA MEDICAL, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K981591 | INTERNATIONAL REGULATORY CONSULTANTS |
2471 E. SHADOW WOOD CIRCLE | SALT LAKE CITY | UT | 84117 |
| K013921 | PORGES S.A. |
CENTRE D'AFFAIRES | LE PLESSIS ROBINSON CEDEX | 92357 | |
| K973504 | PRINCETON REGULATORY ASSOC. |
116 VILLAGE BLVD., SUITE 200 | PRINCETON | NJ | 08540-5799 |
| K173734 | Promepla SAM |
9 Avenue Albert II | Monaco | 98000 | |
| K163068 | Q UROLOGICAL CORPORATION |
15 KEARNCY ROAD | NEEDHAM | MA | 02492 |
| K172289 | Q Urological Corporation |
15 Kearney Road | Needham | MA | 02492 |
| K082805 | Q UROLOGICAL CORPORATION |
1E MELVIN STREET | NATICK | MA | 01760 |
| K212868 | Rocamed SAM |
9 Avenue Albert II | Monaco | 98000 | |
| K982974 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K243830 | Shenzhen Trious Medical Technology Co., Ltd |
Rm 102-2, Longtian Tongfuyu Ind Estate #11-3, and Rm 401 & | Shenzhen | ||
| K213444 | Ureteral Stent Company |
45 Glenridge Court | Chagrin Falls | OH | 44022 |
| K232920 | Ureteral Stent Company |
45 Glenridge Court | Chagrin Falls | OH | 44022 |
| K981491 | UROSURGE, INC. |
116 VILLAGE BLVD., SUITE 200 | PRINCETON | NJ | 08540-5799 |
| K992391 | UROSURGE, INC. |
2660 CROSSPARK RD. | CORALVILLE | IA | 52241 |
| K981489 | UROSURGE, INC. |
116 VILLAGE BLVD., SUITE 200 | PRINCETON | NJ | 08540-5799 |
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