FDA 510(k) Applications for Medical Device:
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K123213 | BECTON DICKINSON & CO. |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K140591 | BECTON DICKINSON & CO. |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K130197 | Becton, Dickinson and Company |
1 BECTON DRIVE MC237 | FRANKLIN LAKES | NJ | 07417 |
| K201099 | Becton, Dickinson and Company |
1 Becton Drive | Franklin Lakes | NJ | 07417 |
| K181221 | Becton, Dickinson and Company |
1 Becton Drive | Franklin Lakes | NJ | 07417 |
| K223076 | CareFusion |
10020 Pacific Mesa Blvd | San Diego | CA | 92121 |
| K222929 | Epic Medical Pte Ltd |
105 Cecil, 20-01 The Octagon | Singapore | 069534 | |
| K251340 | Epic Medical Pte. Ltd. |
105 Cecil Street #20-04, The Octagon | Singapore | 069534 | |
| K241988 | Epic Medical Pte. Ltd. |
105 Cecil Street #20-04, The Octagon | Singapore | 069534 | |
| K192075 | Epic Medical Pte. Ltd. |
10 Jalan Besar, #06-04, Sim Lim Tower | Singapore | 208787 | |
| K241735 | Epic Medical Pte. Ltd. |
105 Cecil Street #20-04, The Octagon | Singapore | 069534 | |
| K240433 | Epic Medical Pte. Ltd. |
105 Cecil Street #20-04, The Octagon, Singapore 069534 | Singapore | 069534 | |
| K240171 | Epic Medical Pte. Ltd. |
105 Cecil , 20-01 The Octagon | Singapore | 069534 | |
| K240517 | Epic Medical Pte. Ltd. |
105 Cecil Street #20-04, The Octagon | Singapore | 069534 | |
| K241823 | Epic Medical Pte. Ltd. |
105 Cecil Street #20-04, The Octagon | Singapore | 069534 | |
| K241476 | Epic Medical Pte. Ltd. |
105 Cecil Street #20-04, The Octagon | Singapore | 069534 | |
| K243976 | Epic Medical Pte. Ltd. |
105 Cecil Street #20-04, The Octagon | Singapore | 069534 | |
| K132899 | EQUASHIELD MEDICAL LTD |
57 LAZY BROOK RD | MONROE | CT | 06468 |
| K150219 | EQUASHIELD MEDICAL LTD |
TEFEN INDUSTRIAL PARK | MIGDAL | 24959 | |
| K170706 | Equashield Medical Ltd. |
tefen industrial park | migdal tefen | 24959 | |
| K221513 | EQUASHIELD Medical Ltd. |
Ktalav St.1, POB 12 | Migdal Tefen | 2495900 | |
| K190157 | ICU Medical |
600 Field Drive | Lake Forest | IL | 60045 |
| K131549 | ICU MEDICAL INC |
4455 ATHERTON DRIVE | SALT LAKE CITY | UT | 84123 |
| K170110 | ICU MEDICAL INC |
951 CALLE AMANECER | SAN CLEMENTE | CA | 92673 |
| K173477 | ICU Medical, Inc. |
600 N. Field Drive | Lake Forest | IL | 60045 |
| K180574 | J & J Solutions, Inc. d/b/a/ Corvida Medical |
2945 Lone Oak Drive, Suite 150 | Eagan | MN | 55121 |
| K150486 | J & J Solutions, Inc. d/b/a/Corvida Medical |
2261 Crosspark Road, Suite 127 | Coralville | IA | 52241 |
| K172499 | JMS North America Corporation |
22320 Foothill Blvd. Suite 350 | Hayward | CA | 94541 |
| K201460 | Shinva Ande Healthcare Apparatus Co., Ltd. |
No.77 Development Zone North Road, New & Hi-Tech Zone | Zibo | 255086 | |
| K192866 | Simplivia Healthcare Ltd. |
North Industrial Zone | Kiryat Shmona | 1101801 | |
| K231286 | Simplivia Healthcare LTD. |
North Industrial Zone | Kiryat Shmona | 1101801 | |
| K210707 | Simplivia Healthcare LTD. |
North Industrial Zone | Kiryat Shmona | 1101801 | |
| K201142 | Simplivia Healthcare Ltd. |
North Industrial Zone | Kiryat Shmona | 1011801 | |
| K170680 | Teva Medical Ltd., Migada Plant |
North Industrial Zone | Kiryat Shmona | 10258 | |
| K180489 | Teva Medical Ltd., Migada Plant |
North Industrial Zone | Kiryat Shmona | 10258 | |
| K141448 | TEVA MEDICAL LTD., MIGADA PLANT |
PIAZZA ALBANIA, 10 | ROME | 00153 | |
| K201422 | Yukon Medical, LLC |
4021 Stirrup Creek Dr Ste 200 | Durham | NC | 27703 |
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