510(k) Report

FDA applicant

Omrix Biopharmaceuticals, Ltd.

Ramat Gan, IL3 decisions2003–20093 recalls

FDA records 3 decisions for Omrix Biopharmaceuticals, Ltd. (Ramat Gan, IL) from 2003 to 2009: 3 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Omrix Biopharmaceuticals, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Omrix Biopharmaceuticals, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2018

2012: 12018: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Omrix Biopharmaceuticals, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Omrix Biopharmaceuticals, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FMFSyringe, Piston2decisions
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K090162Evicel Application DeviceOmrix Biopharmaceuticals, Ltd. · 20091cites it

What has FDA decided for it lately?

  • K090162Evicel Application DeviceOmrix Biopharmaceuticals, Ltd. · 20091 recall
  • K070575Evicel Application DeviceOmrix Biopharmaceuticals, Ltd. · 20071 recall
  • K030032Crosseal Application DeviceOmrix Biopharmaceuticals, Inc. · 20031 recall

All 2 as Omrix Biopharmaceuticals, Ltd. →The one decision as Omrix Biopharmaceuticals, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K070575Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory…Mar 7, 2018Class II
  • K090162EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA…Jul 2, 2012Class II
  • K030032Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups…Aug 6, 2004