FDA applicant
Ellman Intl. Mfg., Inc.
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
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.
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.
See the 510(k) ReportOther applicant names beginning “Ellman”
FDA records each applicant name separately; these may or may not be the same firm.