510(k) Report

FDA applicant

Immedica, Inc.

Chatham, NJ8 decisions1999–20038 recalls

FDA records 8 decisions for Immedica, Inc. (Chatham, NJ) from 1999 to 2003: 8 510(k) clearances. Most are in product codes LXT (Appliance, Fixation, Nail/Blade/Plate…) and LOD (Bone Cement). Its devices cite 1 predicate, 0 of them its own earlier devices. 8 recalls are 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 Immedica, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Immedica, Inc. since 2007.

Recalls per year

7in 2009

2009: 7
2007high 7 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Immedica, 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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