Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list ShenB Co., Ltd. with 11 510(k) clearances. The most recent is a 510(k) clearance dated Apr 10, 2026: Diacore.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Apr 10, 2026 | DiacoreK253926 · NGX | 510(k) clearances |
| Sep 18, 2025 | Sunny Plus (Sunny)K251649 · NFO | 510(k) clearances |
| Mar 19, 2025 | SunnyK242241 · GEI | 510(k) clearances |
| Sep 25, 2024 | Vybe RF IIK241535 · GEI | 510(k) clearances |
| Oct 24, 2023 | PlaDuo SystemK232223 · GEI | 510(k) clearances |
| Jul 6, 2023 | VYBE RF Electrosurgical SystemK230968 · GEI | 510(k) clearances |
| Jul 20, 2022 | AF LaserK221363 · PDZ | 510(k) clearances |
| Nov 23, 2021 | Virtue RFK211562 · GEI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
