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Data / Medical devices / Tonometer, Ac-Powered / Japan

FDA-registered makers of Tonometer, Ac-Powered in Japan: 9 establishments

9 establishments in Japan are registered with the FDA to make Tonometer, Ac-Powered (product code HKX). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Tonometer, Ac-Powered
Product code
HKX
Country
Japan

Makers of Tonometer, Ac-Powered in Japan

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Topcon Corp.Tokyo, JapanSpecification developer2November 7, 2025000api.fda.gov
Canon Components, Inc.KODAMA-GUN Saitama, JapanManufacturer1September 20, 2011000api.fda.gov
Canon Inc.Kawasaki Kanagawa, JapanSpecification developer1September 20, 2011000api.fda.gov
Canon.IncOHTA-KU Tokyo, JapanSpecification developer1September 20, 2011000api.fda.gov
Inami & Co., Ltd.Bunkyo Tokyo, JapanManufacturer1August 2, 1984000api.fda.gov
Nidek Co., Ltd.Gamagori, Aichi, JapanSpecification developer1December 4, 2003000api.fda.gov
Nidek Co., Ltd. Hamacho PlantGamagori, Aichi, JapanManufacturer1December 4, 2003000api.fda.gov
Tomey CorporationNAGOYA Aichi, JapanManufacturer1November 18, 2008000api.fda.gov
Topcon Yamagata Co., LTDYamagata-KEN, JapanContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.