FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Yamaha MotorLabelled 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 Yamaha Motor Corporation, USA with 3 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Mar 19, 2026: JWG-1.
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.
| Mar 19, 2026 | JWG-1K252101 · ITI | 510(k) clearances |
| Apr 17, 2024 | Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-VClass II · Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently | Device recalls |
| Apr 17, 2024 | Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(Class II · Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently | Device recalls |
| May 21, 2021 | JWX-1 Plus (Navigo 16/Navigo 24)K203806 · ITI | 510(k) clearances |
| Aug 28, 2014 | JWX-2K140204 · ITI | 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
