FDA applicant

Ethicon Inc (On Behalf of Omrix Biopharaceuticals

Somerville, NJ1 decision2013–20130 recalls

FDA records 1 decision for Ethicon Inc (On Behalf of Omrix Biopharaceuticals (Somerville, NJ) in 2013: 1 510(k) clearance. All are in product code FMF (Syringe, Piston). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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 Ethicon Inc (On Behalf of Omrix Biopharaceuticals’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Ethicon Inc (On Behalf of Omrix Biopharaceuticals by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Ethicon”

FDA records each applicant name separately; these may or may not be the same firm.

ETHICON, Inc. 213 Ethicon Endo-Surgery, Inc. 186 Ethicon Endo-Sugery, LLC 6 Ethicon Endo-Surgery, LLC (A Johnson and Johnson… 1 Ethicon Endo-Suregery, LLC 1

Ethicon Inc (On Behalf of Omrix Biopharaceuticals

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Ethicon”