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Data / Medical devices / Cannula, Ophthalmic

Cannula, Ophthalmic (HMX): 145 FDA-registered makers in 20 countries

145 establishments in 20 countries are registered with the FDA to make Cannula, Ophthalmic (product code HMX, Class 1, 21 CFR 886.4350). 5 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 77 510(k) clearances under this code, the latest on May 2, 2001, and lists 18 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
HMX
Device class
1
Regulation
886.4350
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States56
Germany24
Pakistan16
India12
China6
Switzerland5
United Kingdom5
France4
Mexico3
Japan2
Netherlands2
Russia2
Italy1
Slovakia1
Dominican Republic1
Mauritius1
South Korea1
Australia1
Indonesia1
Hong Kong1

Makers of Cannula, 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
Iridex CorporationSan Jose, CA, United StatesManufacturer1May 20, 1997000api.fda.gov
Iridex CorporationMountain View, CA, United StatesManufacturer1May 20, 1997000api.fda.gov
Kirwan Surgical Products, LLC.Marshfield, MA, United StatesManufacturer1February 17, 1994000api.fda.gov
Linvatec CorporationLargo, FL, United StatesSpecification developer1September 12, 1977000api.fda.gov
Madhu Instruments Pvt LtdNew Delhi, IndiaManufacturer1May 20, 1997000api.fda.gov
A1 Medical GMBHTuttlingen Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Acme Commercial Ways Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Addn Solutions GMBH & Co. KGWurmlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Akriti Ophthalmic Private LimitedHyderabad Telangana, IndiaManufacturer0000api.fda.gov
Aktive SRLRome Lazio, ItalyManufacturer0000api.fda.gov
Alcon Grieshaber AGNeuhausen Schaffhausen, SwitzerlandSpecification developer0000api.fda.gov
Alcon Grieshaber AGSchaffhausen, SwitzerlandManufacturer0000api.fda.gov
Altomed Ltd.Boldon Colliery South Tyneside, United KingdomManufacturer0000api.fda.gov
Anodyne SurgicalO Fallon, MO, United StatesContract manufacturer, Manufacturer0010api.fda.gov
Appasamy Associates Private Limited ( Thruvandar Koil)Mannadipet Commune Puducherry, IndiaManufacturer0000api.fda.gov
Appasamy Associates Private Limited (MN Kuppam)Villupuram District Tamil Nadu, IndiaManufacturer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Asol Co.,ltdhuaian Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Aurora Surgical, LLCSt Petersburg, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer0000api.fda.gov
Alcon Research, LLCLake Forest, CA, United StatesSpecification developer0000api.fda.gov
Alcon Research, LLCIrvine, CA, United StatesManufacturer0000api.fda.gov
Amann Medical GmbH & Co. KGEmmingen-Liptingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
B&H Surgical InstrumentSialkot Punjab, PakistanManufacturer0000api.fda.gov
BBF Sterilisationsservice GMBHKernen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Bis MastermedKosice Kosicky, SlovakiaManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bright Lights MedicalSaint Louis, MO, United StatesContract manufacturer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedEppelheim Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesManufacturer, Specification developer0050api.fda.gov
Beaver-Visitec International, Inc.Ciudad Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Beaver-Visitec International, LtdBIDFORD-ON-AVON Warwickshire, United KingdomManufacturer0000api.fda.gov
Belle Healthcare Technology Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Blink Medical LTDSolihull, United KingdomRepackager or relabeler, Specification developer0000api.fda.gov
Carl Teufel GMBH & Co. KGLIPTINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Charmant, Inc.Sabae-City, Fukui-Pref., JapanManufacturer0000api.fda.gov
Choose Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Crimson InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicContract manufacturer0000api.fda.gov
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.ZUIDLAND Zuid-Holland, NetherlandsComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Daud Jee MFG CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Duckworth & Kent, Ltd.BALDOCK Hertfordshire, United KingdomManufacturer0000api.fda.gov
Denzel Medical GmbH & Co. KGNEUHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Eagle Labs, LLCSaint Paul, MN, United StatesManufacturer0000api.fda.gov
Emerald InstrumentsSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Endo Tech InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Epsilon Eye Care Pvt., Ltd.MUMBAI Maharashtra, IndiaManufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fabrinal SALA CHAUX-DE-FONDS Neuchatel, SwitzerlandManufacturer0000api.fda.gov
Fci SASBESANCON Doubs, FranceExporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
Fci SudMAPOU LECLEZIO GOODLANDS Riviere du Rempart, MauritiusExporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
Fetzer Medical GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, United StatesManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
Geuder AGHEIDELBERG Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Geuder AGHEIDELBERG Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Gulmag InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Gunther Weiss Scientific Glassblowing Co., Inc.Hillsboro, OR, United StatesManufacturer0000api.fda.gov
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Holger Bumueller LLCRutherfordton, NC, United StatesContract manufacturer0000api.fda.gov
Huaian Frimen Co., LtdHuaian Jiangsu, ChinaManufacturer0000api.fda.gov
Hurricane MedicalBradenton, FL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Iantrek Inc.Providence, RI, United StatesComplaint file establishment, Manufacturer, Specification developer0010api.fda.gov
Inami & Co., Ltd.Bunkyo Tokyo, JapanManufacturer0000api.fda.gov
Incyto Co., Ltd.Cheonan-si Chungnam, South KoreaManufacturer0000api.fda.gov
Indo-German Surgical CorporationMumbai Maharashtra, IndiaExporter to the US, Manufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Iscon Surgicals, Ltd.JODHPUR Rajasthan, IndiaManufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
JR MontagearbeitenTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Johnson & Johnson Surgical Vision, Inc.Irvine, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Kalson SurgicalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Katalyst Surgical, LLCChesterfield, MO, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Katena Products, Inc.Fenton, MO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Katena Products, Inc.Parsippany, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Katena Products, Inc.Randolph, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Kazan Medical Instruments Plant Joint Stock CompanKAZAN Tatarstan, RussiaManufacturer0000api.fda.gov
Kdans Surgical Private LimitedGANDHINAGAR Gujarat, IndiaContract manufacturer0000api.fda.gov
M/S Tarun EnterprisesPrayagraj, Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Medical Instrument Development Laboratories, Inc.San Leandro, CA, United StatesManufacturer0000api.fda.gov
Medicel AGAltenrhein Sankt Gallen, SwitzerlandManufacturer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medone Surgical, Inc.Sarasota, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Mgdinnovations Inc. (mgdi)Tampa, FL, United StatesSpecification developer0000api.fda.gov
Microsurgical Technology, Inc.Redmond, WA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Moria S.A.MASSY Hauts-de-Seine, FranceSpecification developer0000api.fda.gov
Malosa Medical Instruments (Changshu) LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Moria S.ABourbon l'Archambault Allier, FranceContract manufacturer, Exporter to the US0000api.fda.gov
Nova Eye Inc.Fremont, CA, United StatesManufacturer0020api.fda.gov
New World Medical, Inc.Rancho Cucamonga, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Oasis Medical, Inc.Glendora, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Oertel Medical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Pajunk GMBH MedizintechnologieGEISINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Paul Instruments (india)CALCUTTA West Bengal, IndiaManufacturer0000api.fda.gov
PhakosMontreuil Seine-Saint-Denis, FranceManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
PLU OPHTHALMIC CorpCoral Gables, FL, United StatesManufacturer, Specification developer0000api.fda.gov
PMS GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
PT. Ciba Vision BatamBATAM ISLAND Riau, IndonesiaManufacturer0000api.fda.gov
Peregrine Surgical, LLC.New Britain, PA, United StatesManufacturer0000api.fda.gov
RaicoWestmont, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Rumex International Co.Tampa, FL, United StatesManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Sdi Surgical Device International GMBHBruegg Bern, SwitzerlandContract manufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesContract manufacturer0000api.fda.gov
SpeedwayIndia Delhi, IndiaManufacturer0000api.fda.gov
Stephens Instruments, IncLexington, KY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Sterimedix Ltd.REDDITCH Worcestershire, United KingdomContract manufacturer, Manufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer0000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Suqian Zhengtong Medical Instruments Co. LtdChina, Hong KongManufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Surgimed DevicesAHMEDABAD Gujarat, IndiaManufacturer0000api.fda.gov
SurgiscapeSialkot Punjab, PakistanManufacturer0000api.fda.gov
Surgistar, Inc.Vista, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Synergetics, Inc.O Fallon, MO, United StatesManufacturer0010api.fda.gov
Titan SurgicalKAZAN Tatarstan, RussiaManufacturer0000api.fda.gov
Total Titanium, Inc.Red Bud, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
TissueGUARDDresden Saxony, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
VGI medical, LLCLargo, FL, United StatesManufacturer0000api.fda.gov
Visionventions, LLCKirkland, WA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Vitreq BVVierpolders Zuid-Holland, NetherlandsManufacturer, Specification developer0010api.fda.gov
Vista OphthalmicsHouston, TX, United StatesSpecification developer0000api.fda.gov
Vortex Surgical, Inc.Saint Charles, MO, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
WILDmedical GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated May 2, 2001. 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.