FDA 510(k) Applications for Medical Device:
Needle, Fistula
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K112734 | APLAN WELL ENTERPRISE CO., LTD |
NO. 58, FU CHIUN STREET | HSIN CHU CITY | 30067 | |
| K163025 | Bain Medical Equipment (Guangzhou) Co., Ltd. |
No.10 Juncheng Road | Guangzhou | 510760 | |
| K213015 | Bain Medical Equipment (Guangzhou)Co., Ltd. |
No.10, Juncheng Road, Eastern Area, Economic and | Guangzhou | 510760 | |
| K993118 | BIOTEQUE CORP. |
900 N. SWITZER CANYON DR. #142 | FLAGSTAFF | AZ | 86001 |
| K992653 | DIASOL, INC. |
13212 RAYMER ST. | NORTH HOLLYWOOD | CA | 91605 |
| K171505 | Dimesol, Inc. |
509 Fishing Creek Road | Lewisberry | PA | 17339 |
| K001496 | EXELINT INTERNATIONAL CO. |
5840 W. CENTINELA AVE. | LOS ANGELES | CA | 90231-3194 |
| K013037 | EXELINT INTL. CO. |
5840 WEST CENTINELA AVE. | LOS ANGELES | CA | 90045 |
| K023162 | FRESENIUS MEDICAL CARE |
95 HAYDEN AVE. | LEXINGTON | MA | 02420 |
| K990470 | JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU | HIROSHIMA | 730-8652 | |
| K002352 | JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU | HIROSHIMA | 730-8652 | |
| K974902 | JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU | HIROSHIMA | 730-8652 | |
| K990510 | JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU | HIROSHIMA | 730-8652 | |
| K970962 | JMS CO., LTD. |
12,17,KAKO-MACHI,NAKA-KU | HIROSHIMA, 730 | ||
| K000845 | JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU | HIROSHIMA | 730-8652 | |
| K000843 | JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU | HIROSHIMA | 730-8652 | |
| K082882 | JMS NORTH AMERICA CORP. |
55 NORTHERN BLVD. , SUITE 200 | GREAT NECK | NY | 11021 |
| K093637 | JMS NORTH AMERICA CORP. |
1468 HARWELL AVE | CROFTON | MD | 21114 |
| K051814 | JMS NORTH AMERICA CORP. |
22320 FOOTHILL BLVD., | HAYWARD | CA | 94541 |
| K040247 | JMS NORTH AMERICA CORP. |
22320 FOOTHILL BLVD., | HAYWARD | CA | 94541 |
| K112178 | JMS NORTH AMERICA CORPORATION |
1468 HARWELL AVE. | CROFTON | MD | 21114 |
| K151017 | JMS NORTH AMERICA CORPORATION |
22320 FOOTHILL BLVD | HAYWARD | CA | 94541 |
| K142564 | JMS North America Corporation |
22320 Foothill Blvd., Suite 350 | Hayward | CA | 94541 |
| K110157 | JMS NORTH AMERICA CORPORATION |
1468 HARWELL AVE. | CROFTON | MD | 21114 |
| K111948 | JMS NORTH AMERICA CORPORATION |
1468 HARWELL AVE. | CROFTON | MD | 21114 |
| K062953 | MEDISYSTEMS CORP. |
701 PIKE STREET, SUITE 1600 | SEATTLE | WA | 98101-3016 |
| K990803 | MEDISYSTEMS CORP. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006 |
| K991623 | NIPRO MEDICAL CORP. |
1384 COPPERFIELD COURT | LEXINGTON | KY | 40514-1268 |
| K063368 | NIPRO MEDICAL CORP. |
3150 NW 107 AVE.. | MIAMI | FL | 33172 |
| K063721 | NIPRO MEDICAL CORP. |
3150 NW 107 AVE.. | MIAMI | FL | 33172 |
| K093985 | NIPRO MEDICAL CORP. |
3150 NW 107TH AVE. | MIAMI | FL | 33172 |
| K002813 | NIPRO MEDICAL CORP. |
510 STONEMONT DR. | WESTON | FL | 33326 |
| K100520 | NIPRO MEDICAL CORPORATION |
3150 N.W. 107TH AVE. | MIAMI | FL | 33172 |
| K955182 | NISSHO CORP. |
7205 CORPORATE CENTER DR. | MIAMI | FL | 33126 |
| K134019 | NXSTAGE MEDICAL, INC. |
350 MERRIMACK STREET | LAWRENCE | MA | 01843 |
| K013384 | SHARGH PHARMACEUTICAL CO., INC. |
5840 WEST CENTINELA AVE. | LOS ANGELES | CA | 90045 |
| K131950 | SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC. |
7 MEADOW WOOD ROAD | KINGSTON | NH | 03848 |
| K003123 | SUNDER BIOMEDICAL TECH. CO., LTD. |
10F-1, 1-67, WU-CHUAN RD. | TAICHUNG CITY | 403 | |
| K052267 | TOGO MEDIKIT CO., LTD. |
4-2-1 YUSHIMA BUNKYO-KU | TOKYO | 113-0034 |
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