Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list H&Abyz Co., Ltd. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Aug 4, 2025: HnX-P1, HnX-PB.
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.
| Aug 4, 2025 | HnX-P1, HnX-PBK251223 · IZL | 510(k) clearances |
| Mar 6, 2023 | A1417MCW/A1717MCW/F1417MCWK223930 · MQB | 510(k) clearances |
| Nov 15, 2021 | ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)K213497 · MQB | 510(k) clearances |
| Mar 12, 2021 | ADDK203188 · MQB | 510(k) clearances |
| Jan 31, 2020 | HAD1717MCK200018 · MQB | 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
