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Data / Medical devices / Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Instrument, Vitreous Aspiration And Cutting, Ac-Powered (HQE): 22 FDA-registered makers in 7 countries

22 establishments in 7 countries are registered with the FDA to make Instrument, Vitreous Aspiration And Cutting, Ac-Powered (product code HQE, Class 2, 21 CFR 886.4150). 11 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 149 510(k) clearances under this code, the latest on August 10, 2022, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HQE
Device class
2
Regulation
886.4150
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States13
Switzerland3
Mexico2
Indonesia1
China1
Germany1
Netherlands1

Makers of Instrument, Vitreous Aspiration And Cutting, Ac-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
Medical Instrument Development Laboratories, Inc.San Leandro, CA, United StatesContract manufacturer, Manufacturer3April 29, 2016000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer2April 29, 2016030api.fda.gov
Bausch & Lomb IncorporatedSaint Louis, MO, United StatesManufacturer, Repackager or relabeler2April 29, 2016010api.fda.gov
Alcon Grieshaber AGSchaffhausen, SwitzerlandManufacturer1August 22, 2014010api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer1August 22, 2014000api.fda.gov
Alcon Research, LLCLake Forest, CA, United StatesSpecification developer1August 22, 2014000api.fda.gov
Alcon Research, LLCIrvine, CA, United StatesManufacturer1August 22, 2014000api.fda.gov
Alcon Research, LLCHouston, TX, United StatesManufacturer1August 22, 2014000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer, Repackager or relabeler1April 29, 2002000api.fda.gov
PT. Ciba Vision BatamBATAM ISLAND Riau, IndonesiaManufacturer1August 22, 2014000api.fda.gov
Synergetics, Inc.O Fallon, MO, United StatesManufacturer1February 23, 1994010api.fda.gov
ABA Medical Technology Co LtdGuang dong Guangdong, ChinaContract manufacturer0000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer0000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Carl Zeiss Meditec AG (oberkochen)OBERKOCHEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.ZUIDLAND Zuid-Holland, NetherlandsComplaint file establishment, Manufacturer, Repackager or relabeler0010api.fda.gov
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Microsurgical Technology, Inc.Redmond, WA, United StatesContract manufacturer0000api.fda.gov
Oertli Instrumente AGBERNECK Sankt Gallen, SwitzerlandManufacturer0000api.fda.gov
Peregrine Surgical, LLC.New Britain, PA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
This AGHeerbrugg Sankt Gallen, SwitzerlandExporter to the US, Manufacturer0000api.fda.gov
Zevex, Inc.Salt Lake City, UT, United StatesContract manufacturer0000api.fda.gov

Updated August 10, 2022. 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.