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Data / Medical devices / Bur, Ear, Nose And Throat

Bur, Ear, Nose And Throat (EQJ): 54 FDA-registered makers in 14 countries

54 establishments in 14 countries are registered with the FDA to make Bur, Ear, Nose And Throat (product code EQJ, Class 1, 21 CFR 874.4140). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on January 17, 2017, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
EQJ
Device class
1
Regulation
874.4140
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
United States23
Germany10
China5
India3
Ireland2
Switzerland2
Dominican Republic2
Turkey1
South Africa1
Nicaragua1
Pakistan1
France1
Mexico1
Japan1

Makers of Bur, Ear, Nose And Throat

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
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer2August 12, 2004030api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer1July 28, 1995000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer1June 5, 1995000api.fda.gov
Sanmed Medikal Otomotiv Tekstil Ticaret Limited SirketiIstanbul, TurkeyExporter to the US, Manufacturer1January 17, 2017000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1January 17, 2017000api.fda.gov
Stryker Ireland Ltd. Instruments Division, Innovation CentreCarrigtwohill Cork(County), IrelandSpecification developer1January 17, 2017000api.fda.gov
ABBOTT GmbHWiesbaden Hesse, GermanyManufacturer0000api.fda.gov
Acumed Instruments Corp.Santa Barbara, CA, United StatesSpecification developer0000api.fda.gov
B & M Precision, Inc.Ruskin, FL, United StatesContract manufacturer0000api.fda.gov
Bien-Air Surgery SALe Noirmont Jura, SwitzerlandExporter to the US, Foreign private label distributor, Manufacturer, Specification developer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Berger Surgical Medical Products GmbHNeuhausen ob Eck Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
CEA Global Dominicana d.b.a. Nissha Medical TechnologiesSan Pedro de Macoris, Dominican RepublicContract manufacturer0000api.fda.gov
Coba Biomedical Pty (ltd)Bloemfontein Free State, South AfricaContract manufacturer0000api.fda.gov
Command Medical Nicaragua SAManagua, NicaraguaContract manufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicContract manufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Eon Meditech Pvt. Ltd.Surat Gujarat, IndiaComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Evonos GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Eberle GmbH & Co. KGWURMBERG Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Grace Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Guizhou Zirui Technology Co., Ltd.Tongzi County, Zunyi Guizhou, ChinaManufacturer0000api.fda.gov
Gyrus Acmi, Inc.Bartlett, TN, United StatesManufacturer, Repackager or relabeler0010api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hafner Chirurgische InstrumenteBALGHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hager & Meisinger GMBHNEUSS North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Integra Microfrance SASSAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FranceManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Repackager or relabeler0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
Manman Manufacturing Company Private LimitedPune Maharashtra, IndiaManufacturer0000api.fda.gov
Medtronic Powered Surgical SolutionsFort Worth, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
MSK Precision Products, Inc.Tamarac, FL, United StatesContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
Nakanishi Inc.Kanuma Tochigi, JapanContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Renovo, Inc.Bend, OR, United StatesReprocessor0000api.fda.gov
Stryker Ireland Ltd., Instruments DivisionCARRIGTWOHILL, CO.CORK Munster, IrelandContract manufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer0000api.fda.gov
Suretek MedicalGreenville, SC, United StatesReprocessor0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
The Anspach Effort, Inc.Palm Bch Gdns, FL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Tribest Dental Products Co LtdYangzhong Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Zonefly Medical Devices Co., Ltd.Danyang Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated January 17, 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.