FDA applicant
Guilin Refine Medical Instrument Co., Ltd.
FDA records 3 decisions for Guilin Refine Medical Instrument Co., Ltd. (Guilin, CN) from 2023 to 2026: 3 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and EBZ (Activator, Ultraviolet, For Polymerization). Since 2016 its 510(k)s took a median of 258 days from receipt to decision, against 255 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Guilin Refine Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Guilin Refine Medical Instrument Co.…’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 “Guilin”
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