510(k) Report

FDA applicant

Li Medical Technologies, Inc.

Shelton, CT17 decisions1993–20000 recalls

FDA records 17 decisions for Li Medical Technologies, Inc. (Shelton, CT) from 1993 to 2000: 17 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and MAI (Fastener, Fixation, Biodegradable, Soft Tissue). Its devices cite 28 predicates, 18 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Li Medical Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Li Medical Technologies, 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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