FDA applicant
Sunnex, Inc.
FDA records 2 decisions for Sunnex, Inc. (Charlotte, NC) from 1985 to 2014: 2 510(k) clearances. Most are in product codes FSY (Light, Surgical, Ceiling Mounted) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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 Sunnex, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sunnex, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sunnex”
FDA records each applicant name separately; these may or may not be the same firm.