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Data / Medical devices / Spud, Ophthalmic

Spud, Ophthalmic (HNA): 67 FDA-registered makers in 11 countries

67 establishments in 11 countries are registered with the FDA to make Spud, Ophthalmic (product code HNA, Class 1, 21 CFR 886.4350). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on August 31, 1993, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HNA
Device class
1
Regulation
886.4350
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States22
Pakistan14
Germany11
India9
China4
United Kingdom2
Slovakia1
South Africa1
United Arab Emirates1
Latvia1
Hong Kong1

Makers of Spud, 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
66 Vision Tech Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
A1 Medical GMBHTuttlingen Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Acme Commercial Ways Ltd.Sialkot Punjab, PakistanManufacturer0000api.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
Aurora Surgical, LLCSt Petersburg, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Avilign MedicalSialkot Punjab, PakistanContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
B&H Surgical InstrumentSialkot Punjab, PakistanManufacturer0000api.fda.gov
Bernhard FreyTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Bis MastermedKosice Kosicky, SlovakiaManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bruder Healthcare CompanyFairfield, OH, United StatesSpecification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesSpecification developer0000api.fda.gov
Beaver-Visitec International, LtdBIDFORD-ON-AVON Warwickshire, United KingdomManufacturer0000api.fda.gov
Belle Healthcare Technology Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Carl Teufel GMBH & Co. KGLIPTINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Coba Biomedical Pty (ltd)Bloemfontein Free State, South AfricaContract manufacturer0000api.fda.gov
Crown Surgical Corp.Sialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Daud Jee MFG CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Diligent Medical ServicesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Empire Surgical Instruments CompanySialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Epsilon Eye Care Pvt., Ltd.MUMBAI Maharashtra, IndiaManufacturer0000api.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
Geuder AGHEIDELBERG Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Geuder AGHEIDELBERG Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Gulden OphthalmicsElkins Park, PA, United StatesManufacturer0000api.fda.gov
Hafner Chirurgische InstrumenteBALGHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
HGR Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Huaian Tisurg Medical Instruments Co., Ltd.Huaian City Jiangsu, ChinaManufacturer0000api.fda.gov
Indo-German Surgical CorporationMumbai Maharashtra, IndiaExporter to the US, Manufacturer0000api.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
Katena Products, Inc.Fenton, MO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Katena Products, Inc.Parsippany, NJ, United StatesSpecification developer0000api.fda.gov
Katena Products, Inc.Randolph, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Kdans Surgical Private LimitedGANDHINAGAR Gujarat, IndiaContract manufacturer0000api.fda.gov
M.J. Instruments Company (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
M/S Tarun EnterprisesPrayagraj, Uttar Pradesh, IndiaManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Mian Shahid Corp.MUZAFFAR PUR, SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Mount Blonck TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Malosa Medical Instruments (Changshu) LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Optego Vision USA, Inc.Tucson, AZ, United StatesManufacturer, Specification developer0000api.fda.gov
Paul Instruments (india)CALCUTTA West Bengal, IndiaManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Perfect Ophthalmic Instruments FZEDubai Dubayy, United Arab EmiratesManufacturer0000api.fda.gov
RUMEX Baltics SIARiga, LatviaManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Spartech Instruments & Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
SpeedwayIndia Delhi, IndiaManufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Suqian Zhengtong Medical Instruments Co. LtdChina, Hong KongManufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
Surtex Instruments LtdLondon Surrey, United KingdomManufacturer0000api.fda.gov
Total Titanium, Inc.Red Bud, IL, United StatesContract manufacturer, Manufacturer, Remanufacturer0000api.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

Updated August 31, 1993. 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.