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Data / Medical devices / Stand, Instrument, Ac-Powered, Ophthalmic

Stand, Instrument, Ac-Powered, Ophthalmic (HMF): 25 FDA-registered makers in 12 countries

25 establishments in 12 countries are registered with the FDA to make Stand, Instrument, Ac-Powered, Ophthalmic (product code HMF, Class 1, 21 CFR 886.1860). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on April 19, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
HMF
Device class
1
Regulation
886.1860
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States10
Germany2
China2
India2
Japan2
Spain1
Brazil1
Canada1
Italy1
Taiwan1
Poland1
Mexico1

Makers of Stand, Instrument, Ac-Powered, Ophthalmic

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Antoni Carles, S.A.VILASSAR DE MAR Barcelona, SpainContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Apramed Industria E Comercio De Aparelhos Medicos LtdaSAO CARLOS Sao Paulo, BrazilManufacturer0000api.fda.gov
Atricure, Inc.Mason, OH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Alcon Research, LLCLake Forest, CA, United StatesSpecification developer0000api.fda.gov
Alcon Research, LLCIrvine, CA, United StatesManufacturer0000api.fda.gov
Apramed USA LLCKissimmee, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Blue.s4Belleville Ontario, CanadaManufacturer0000api.fda.gov
C.S.O. S.R.L.Scandicci Firenze, ItalyManufacturer0000api.fda.gov
Carl Zeiss Vision GMBHAALEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Eyecheq, IncMiami, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Haag-Streit Usa, Inc.Mason, OH, United StatesManufacturer0000api.fda.gov
Hanson & Zollinger IncBerlin, NJ, United StatesContract manufacturer0000api.fda.gov
Heine Optotechnik GMBH & Co. KG.GILCHING Bavaria, GermanyManufacturer0000api.fda.gov
Kuang Yeu Medical Co., Ltd.Taichung City, TAIWAN, TaiwanManufacturer0000api.fda.gov
Lianyungang Tiannuo Optical Instrument Co., Ltd.LIANYUNGANG Jiangsu, ChinaContract manufacturer, Repackager or relabeler0000api.fda.gov
M/S Tarun EnterprisesPrayagraj, Uttar Pradesh, IndiaManufacturer0000api.fda.gov
MDT SP. Z O.O.KRAKOW Malopolskie, PolandManufacturer0000api.fda.gov
Myvision Medical Pvt. Ltd.Ahmedabad Gujarat, IndiaManufacturer0000api.fda.gov
Ray Vision Inc.Lake Forest, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Takagi Seiko Co., Ltd.NAKANO-SHI Nagano, JapanExporter to the US, Manufacturer0000api.fda.gov
Towa Medical Instruments Co.,ltd.Nakano-shi Nagano, JapanContract manufacturer, Manufacturer0000api.fda.gov
Taiyuan North China Xinyuan Tech. Center (Co., LTD.)TAIYUAN Shaanxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Topcon Healthcare, Inc.Oakland, NJ, United StatesSpecification developer0000api.fda.gov
Welch Allyn De Mexico, S. De R.L. De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesManufacturer0000api.fda.gov

Updated April 19, 1994. 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.