FDA applicant

Ellman Int'L, Inc.

Oceanside, NY6 decisions2005–20111 recall

FDA records 6 decisions for Ellman Int'L, Inc. (Oceanside, NY) from 2005 to 2011: 6 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 12 predicates, 5 of them its own earlier devices. 1 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 and plastic surgery panel, where it files most

How often FDA has decided Ellman Int'L, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ellman Int'L, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ellman Int'L, Inc.’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 “Ellman”

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

Ellman Intl., Inc. 15 Ellman International, Inc. 5 Ellman Intl. Mfg., Inc. 2

Ellman Int'L, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Ellman”