FDA applicant
Gensia, Inc.
FDA records 1 decision for Gensia, Inc. (San Diego) in 1997: 1 original PMA approval. All are in product code MQT (Pump, Drug Administration, Closed Loop). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Gensia, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Gensia, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Gensia, 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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