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

Stand, Instrument, Ophthalmic, Non-Powered (HMG): 15 FDA-registered makers in 7 countries

15 establishments in 7 countries are registered with the FDA to make Stand, Instrument, Ophthalmic, Non-Powered (product code HMG, 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 4 510(k) clearances under this code, the latest on February 16, 1990, 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
HMG
Device class
1
Regulation
886.1860
Medical specialty
Ophthalmic

Makers by country

CountryMakers
India6
United States3
Pakistan2
Japan1
Poland1
Germany1
China1

Makers of Stand, Instrument, Ophthalmic, Non-Powered

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
Appasamy Associates Private Limited ( Ambattur)Chennai Tamil Nadu, IndiaManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Good-Lite Co.Elgin, IL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Inami & Co., Ltd.Bunkyo Tokyo, JapanManufacturer0000api.fda.gov
Indo-German Surgical CorporationMumbai Maharashtra, IndiaExporter to the US, Manufacturer0000api.fda.gov
Konan Medical Usa, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer0000api.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
Paul Instruments (india)CALCUTTA West Bengal, IndiaManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Towne Brothers (pvt.), Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
United Poly Engineering Pvt. Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Volk Optical Inc.Mentor, OH, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov

Updated February 16, 1990. 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.