FDA 510(k) Applications for Medical Device:
Injector, Contrast Medium, Automatic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K984058 | ACIST MEDICAL SYSTEMS |
10250 VALLEY VIEW RD., #117 | EDEN PRAIRIE | MN | 55344 |
| K151048 | BRACCO INJENEERING |
AVENUE DE SEVELIN 46 | LAUSANNE | CH-1004 | |
| K031571 | E-Z-EM, INC. |
717 MAIN ST. | WESTBURY | NY | 11590 |
| K062449 | E-Z-EM, INC. |
750 SUMMA AVE. | WESTBURY | NY | 11590 |
| K152361 | Liebel-Flarsheim Company LLC |
2111 East Galbraith Rd | Cincinnati | OH | 45237 |
| K063503 | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. | CINCINNATI | OH | 45237 |
| K063090 | MEDRAD, INC. |
ONE MEDRAD DR. | INDIANOLA | PA | 15051 |
| K091734 | NEMOTO KYORINDO CO., LTD. |
2-12-4 AOKI | KAWAGUCHI-SHI, SAITAMA | 332-0031 | |
| K983314 | NYCOMED AMERSHAM IMAGING |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K062265 | SWISS MEDICAL CARE S.A. |
32 STRATTON COURT | FLEMINGTON | NJ | 08822 |
| K171392 | ulrich GmbH & Co. KG |
Buchbrunnenweg 12 | Ulm | 89081 | |
| K192872 | ulrich GmbH & Co. KG |
Buchbrunnenweg 12 | Ulm | 89081 | |
| K210541 | ulrich GmbH & Co. KG |
Buchbrunnenweg 12 | Ulm | 89081 |
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