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Data / Medical devices / Source, Carrier, Fiberoptic Light

Source, Carrier, Fiberoptic Light (EQH): 63 FDA-registered makers in 12 countries

63 establishments in 12 countries are registered with the FDA to make Source, Carrier, Fiberoptic Light (product code EQH, Class 1, 21 CFR 874.4350). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 49 510(k) clearances under this code, the latest on December 4, 1995, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
EQH
Device class
1
Regulation
874.4350
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
United States22
Germany20
China6
Pakistan4
Japan2
Australia2
France2
Argentina1
Mexico1
India1
Spain1
Bulgaria1

Makers of Source, Carrier, Fiberoptic Light

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
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1May 22, 1987000api.fda.gov
Integra LifeSciences CorporationPrinceton, NJ, United StatesComplaint file establishment, Specification developer1May 22, 1987000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer1May 22, 1987000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer, Specification developer1May 22, 1987000api.fda.gov
Acclarent, Inc.Irvine, CA, United StatesSpecification developer0000api.fda.gov
Aizu Olympus Co., Ltd.AIZUWAKAMATSU-SHI Fukushima, JapanManufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Atmos Medizintechnik GMBH & Co. KGLENZKIRCH Baden-Wurttemberg, GermanyExporter to the US, Manufacturer0000api.fda.gov
Anhui Shiyin Photoelectric Instrument Co., Ltd.Suzhou Anhui, ChinaManufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Bear-Ent, LLCMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Beijing Fanxing Guangdian Medical Treatment Equipment Co LtdBeijing, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Doctor DevicesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Ecleris SRLVilla Martelli Buenos Aires, ArgentinaManufacturer0000api.fda.gov
Elmed, Inc.Glendale Heights, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Eusa Global LLCMedley, FL, United StatesContract manufacturer0000api.fda.gov
Evonos GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Fentexmedical GMBHNEUHAUSEN, BW Baden-Wurttemberg, GermanyContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Fiberoptics Technology, Inc.Pomfret, CT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Guangzhou T.K Medical Instrument Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Innomed, Inc.Savannah, GA, United StatesRepackager or relabeler, Specification developer0000api.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
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Mattes Instrumente GMBHTuttlingen-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Meril Life Sciences Pvt. Ltd.Vapi Gujarat, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer0000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Ondine Research Laboratories/Ondine Biomedical Inc. (us)Bothell, WA, United StatesComplaint file establishment, Manufacturer for export, Repackager or relabeler, Specification developer0000api.fda.gov
Optomic Espana, S.A.COLMENAR VIEJO Madrid(Province), SpainManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Rudolf Riester GMBHJUNGINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Schoelly Fiberoptic, GMBHDENZLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Schoelly-Optix OodPanagyurishte Pazardzhik, BulgariaContract manufacturer0000api.fda.gov
Schott North America Inc - Lighting And ImagingSouthbridge, MA, United StatesManufacturer, Specification developer0000api.fda.gov
Shenzhen Eyco Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
SoproLA CIOTAT CEDEX Bouches-du-Rhone, FranceManufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer0000api.fda.gov
Sunoptic Technologies, LLCJacksonville, FL, United StatesManufacturer0000api.fda.gov
Swantia Medical Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Swengg CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Shenzhen Shanglaite Electronic Technology Co. LTDShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Tigris Elektronik GMBHBerlin, GermanyContract 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
VorotekMoolap Victoria, AustraliaManufacturer0000api.fda.gov
Weco Manufacturing Group-HenriettaRochester, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Xuzhou AKX Electronic Science and Technology Co., Ltd.Xuzhou Jiangsu, ChinaManufacturer0000api.fda.gov

Updated December 4, 1995. 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.