510(k) Report

FDA applicant

Lorad Corp.

Danbury, CT12 decisions1994–19990 recalls

FDA records 12 decisions for Lorad Corp. (Danbury, CT) from 1994 to 1999: 12 510(k) clearances. Most are in product codes IZH (System, X-Ray, Mammographic) and GEX (Powered Laser Surgical Instrument). Its devices cite 6 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, radiology panel, where it files most

How often FDA has decided Lorad Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lorad Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lorad Corp.’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 “Lorad”

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