FDA applicant

Ellman International, Inc.

Oceanside, NY5 decisions2006–20141 recall

FDA records 5 decisions for Ellman International, Inc. (Oceanside, NY) from 2006 to 2014: 5 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and PBX (Massager, Vacuum, Radio Frequency Induced Heat). Its devices cite 4 predicates, 0 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 International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ellman International, 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 Int'L, Inc. 6 Ellman Intl. Mfg., Inc. 2

Ellman International, 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”