FDA applicant
Zomed Intl.
FDA records 7 decisions for Zomed Intl. (Mountain View, CA) from 1995 to 1996: 7 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and FLL (Continuous Measurement Thermometer). 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 Zomed Intl.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Zomed Intl. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Zomed Intl.’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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