FDA applicant

Ellman Intl., Inc.

Hewlett, NY15 decisions1996–20010 recalls

FDA records 15 decisions for Ellman Intl., Inc. (Hewlett, NY) from 1996 to 2001: 15 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered). Its devices cite 4 predicates, 2 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Ellman Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ellman Intl., 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 Int'L, Inc. 6 Ellman International, Inc. 5 Ellman Intl. Mfg., Inc. 2

Ellman Intl., 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?

Other applicant names beginning “Ellman”