FDA applicant
Immedica, Inc.
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
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
Class I Class II/III not classified
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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