510(k) Report

FDA applicant

Ellman Intl. Mfg., Inc.

Port Jefferson, NY2 decisions1991–19920 recalls

FDA records 2 decisions for Ellman Intl. Mfg., Inc. (Port Jefferson, NY) from 1991 to 1992: 2 510(k) clearances. Most are in product codes HGI (Electrocautery, Gynecologic (And Accessories)) and GCI (Laryngoscope, Endoscope). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ellman Intl. Mfg., 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.