FDA applicant

Paradigm Medical Industries, Inc.

Salt Lake City, UT10 decisions1995–20050 recalls

FDA records 10 decisions for Paradigm Medical Industries, Inc. (Salt Lake City, UT) from 1995 to 2005: 10 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and GEX (Powered Laser Surgical Instrument). Its devices cite 2 predicates, 1 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, ophthalmic panel, where it files most

How often FDA has decided Paradigm Medical Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Paradigm Medical Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Paradigm Medical Industries, 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 “Paradigm”

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

Paradigm Spine, LLC 16 Paradigm Medical, Inc. 3 Paradigm Trex, LLC 1 Paradigm Lasers, Inc. 1

Paradigm Medical Industries, 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 “Paradigm”