510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Yamaha Motor Co Ltd

Iwata Shizuoka, JP

YAMAHA MOTOR CO LTD appears in FDA device records in Iwata Shizuoka, JP. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Yamaha Motor Co Ltd between 2014 and 2026. The busiest year on record is 2014, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Yamaha Motor Co Ltd, by decision year
YearClearances
20141
20211
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252101JWG-1ITISubstantially Equivalent
K203806JWX-1 Plus (Navigo 16/Navigo 24)ITISubstantially Equivalent
K140204JWX-2ITISubstantially Equivalent

Registered establishments

FDA registered establishments for Yamaha Motor Co Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30011858283001185828YAMAHA MOTOR CO LTD2500 Shingai, Iwata Shizuoka 4388501 JP2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1816-2024Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-VNon-medical laser products which were determined to not be in compliance with 21 C.F.R. 1010.2 in that they currently do not bear the required certification label.Class IIOpen, Classified
Z-1815-2024Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSDNon-medical laser products which were determined to not be in compliance with 21 C.F.R. 1010.2 in that they currently do not bear the required certification label.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain