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Data / Medical devices / Syringe, Cartridge

Syringe, Cartridge (EJI): 50 FDA-registered makers in 17 countries

50 establishments in 17 countries are registered with the FDA to make Syringe, Cartridge (product code EJI, Class 2, 21 CFR 872.6770). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 45 510(k) clearances under this code, the latest on November 16, 2017, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
EJI
Device class
2
Regulation
872.6770
Medical specialty
Dental

Makers by country

CountryMakers
Pakistan19
United States9
South Korea4
France3
United Kingdom2
China2
Denmark1
Canada1
Poland1
Brazil1
Australia1
India1
Italy1
United Arab Emirates1
Latvia1
Germany1
Switzerland1

Makers of Syringe, Cartridge

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
Milestone Scientific, Inc.Roseland, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer3August 8, 2006010api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer2October 30, 2014000api.fda.gov
Accompany SurgicalSIALKOT Punjab, PakistanManufacturer1November 6, 2012000api.fda.gov
Goldstar Medical InstrumentsSIALKOT Punjab, PakistanManufacturer1November 6, 2012000api.fda.gov
Hu-Friedy MFG. Co. LLCNorthbrook, IL, United StatesManufacturer, Repackager or relabeler, Specification developer1November 6, 2012000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer1November 6, 2012000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer1July 16, 1984000api.fda.gov
Ronvig Dental MFG. A/SDAUGAARD Midtjylland, DenmarkManufacturer1October 13, 2000000api.fda.gov
SeptodontCEDEX Val-de-Marne, FranceContract manufacturer, Manufacturer1July 11, 1995000api.fda.gov
Sofic SASMazamet, Cedex Tarn, FranceManufacturer1July 11, 1995000api.fda.gov
Acme Commercial Ways Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Arnold Tuber IndustriesOrchard Park, NY, United StatesContract manufacturer0000api.fda.gov
B&H Surgical InstrumentSialkot Punjab, PakistanManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Beyes Dental IncToronto Ontario, CanadaManufacturer0000api.fda.gov
Bailey Instruments LtdManchester, United KingdomManufacturer0000api.fda.gov
Confident InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Densol International (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Denta Craft InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dental Hi TecMazieres en Mauges Maine-et-Loire, FranceManufacturer0000api.fda.gov
Dental StudioAnyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Dentis Medical DivisionDaegu, South KoreaManufacturer0000api.fda.gov
DTR Medical LtdSwansea, United KingdomManufacturer0000api.fda.gov
Emerald InstrumentsSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Foshan Coxo Medical Instrument Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka KomandytowaRUDNIKI K/CZESTOCHOWY Slaskie, PolandManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Guilin Woodpecker Medical Instrument Co., LtdGUILIN CITY Guangxi, ChinaManufacturer0000api.fda.gov
Hexa DentalCommerce, CA, United StatesContract manufacturer0000api.fda.gov
Indusbello Industria De Instrumentos OdoLondrina Parana, BrazilManufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Jaffrose InternationalSialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Lacigrus InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Laparomed Private LimitedMumbai Maharashtra, IndiaManufacturer0000api.fda.gov
Lohar Medical CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
MEDESY srlMANIAGO Pordenone, ItalyContract manufacturer0000api.fda.gov
Medihub Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Nextcon InternationalSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Perfect Ophthalmic Instruments FZEDubai Dubayy, United Arab EmiratesManufacturer0000api.fda.gov
RUMEX Baltics SIARiga, LatviaManufacturer0000api.fda.gov
Signor Seven InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Silver Plus Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Tricor SystemsElgin, IL, United StatesContract manufacturer0000api.fda.gov
Wise InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Young Innovations Inc.Algonquin, IL, United StatesSpecification developer0000api.fda.gov
medmix Switzerland AGHaag Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov

Updated November 16, 2017. 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.