# Omrix Biopharmaceuticals, Ltd.

- Location (FDA's records): Ramat Gan, IL
- FDA decisions: 3 (2003–2009): 3 510(k) clearances
- Names in FDA's records: Omrix Biopharmaceuticals , Ltd. (2); Omrix Biopharmaceuticals, Inc. (1)
- Product codes: FMF (2), FMI (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Immuno-U.S., Inc.: 1 (https://510kreport.com/company/immuno-us)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)

## Firms that cite its devices most
- Ethicon Inc (On Behalf of Omrix Biopharaceuticals: 1 (https://510kreport.com/company/ethicon-on-behalf-of-omrix-biopharaceuticals)

## Its most-cited devices
- K090162: Evicel Application Device (2009), cited by 1

## Recent decisions
- K090162: Evicel Application Device (Feb 20, 2009)
- K070575: Evicel Application Device (May 29, 2007)
- K030032: Crosseal Application Device (Mar 21, 2003)

Source page: https://510kreport.com/company/omrix-biopharmaceuticals