ASCENIV
HUMAN IMMUNOGLOBULIN G
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2243374 | 1000122327 | ADM TRONICS UNLTD, INC. | 1 | N | 2026-01-01 | 224S PEGASUS AVE NORTHVALE NJ US 07647 |
| 3003956144 | 3003956144 | ADMEDES GMBH | 1 | N | 2026-01-01 | RASTATTER STRASSE 15 PFORZHEIM Baden-Wurttemberg DE 75179 |
| 3005347791 | 3005347791 | ADM, a.s. | 1 | N | 2026-01-01 | U Vodarny 2 Brno Mesto Brno CZ 61600 |
| 3008492676 | 3008492676 | ADMEDES INC. | 1 | N | 2026-01-01 | 2800 Collier Canyon Road Livermore CA US 94551 |
| 3010057321 | 3010057321 | ADMI | 1 | Y | 2026-01-01 | 281 Sanders Creek Pkwy East Syracuse NY US 13057 |
| 3014414462 | 3014414462 | ADMETEC SOLUTION LTD | 1 | N | 2026-01-01 | Yokhanan HaSandlar St. 18 Haifa IL 3296218 |
| 3013642758 | 3013642758 | ADM PROMOTIONS USA, INC | 1 | Y | 2020-04-25 | 78 Southfield Avenue Suite 203 Stamford CT US 06902 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 24423 | 1755290857 | K952353 | EZ-COMP | EBF | 1995-08-10 |
| 292740 | 1656012061 | K891895 | SURGICAL LOUPES | FSP | 1989-04-12 |
| 65690 | 1628154111 | K040930 | ZILVER BILIARY STENT SYSTEM USW | FGE | 2004-07-02 |
| 65690 | 1951833147 | K031821 | MODIFICATION TO COOK ZILVER BILIARY STENT | FGE | 2003-07-18 |
| 152595 | 1478685408 | ||||
| 152595 | 1633646209 | ||||
| 152595 | 1680508267 | ||||
| 152595 | 1858778350 | ||||
| 36322 | 1051524472 | ||||
| 65690 | 1117094608 | ||||
| 292740 | 1123782375 | ||||
| 119215 | 1171626050 | ||||
| 36322 | 1378889948 | ||||
| 36322 | 1413298224 | ||||
| 36322 | 1532983231 | ||||
| 36322 | 1738416502 | ||||
| 36322 | 1799542628 |
HUMAN IMMUNOGLOBULIN G
Hepatitis B Immune Globulin (Human)
Immune Globulin Intravenous (Human) 10%
Immune Globulin Intravenous (Human) 10%
Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate
Zinc Oxide
Homosalate, Ethylhexyl Methoxycinnamate,Titanium Dioxide
Homosalate, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate
Zinc Oxide, Homosalate, Octocrylene
Adm Diagnostics, Inc.
Admedus Regen Pty Ltd
Admedus Regen Pty Ltd
Admedus Regen Pty Ltd
ADM TRONICS UNLTD, INC.
ADM, INC.