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Data / Medical devices / Led Light Source

Led Light Source (NTN): 67 FDA-registered makers in 13 countries

67 establishments in 13 countries are registered with the FDA to make Led Light Source (product code NTN, Class 2, 21 CFR 876.1500). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on March 16, 2015, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
NTN
Device class
2
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States22
China13
Germany10
Japan9
Switzerland2
Ireland2
India2
South Korea2
France1
Argentina1
Italy1
Bulgaria1
Australia1

Makers of Led Light Source

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
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1July 28, 2009000api.fda.gov
Fiberoptics Technology, Inc.Pomfret, CT, United StatesManufacturer, Repackager or relabeler1August 17, 2010000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer1December 14, 2012000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyManufacturer1July 30, 2014000api.fda.gov
Optim LLCSturbridge, MA, United StatesManufacturer1July 28, 2009000api.fda.gov
Shirakawa Olympus Co., Ltd.NISHISHIRAKAWA-GUN Fukushima, JapanManufacturer1December 14, 2012000api.fda.gov
SoproLA CIOTAT CEDEX Bouches-du-Rhone, FranceManufacturer1March 22, 2011000api.fda.gov
Ackermann Instrumente GMBHRIETHEIM, WEILHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aizu Olympus Co., Ltd.AIZUWAKAMATSU-SHI Fukushima, JapanManufacturer0000api.fda.gov
Anqing Changfan Medical Instrument Co., LtdAnqing Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ars Co., Ltd.Kofu Yamanashi, JapanManufacturer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer0000api.fda.gov
Bruetsch Technology AGBeringen Schaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer0000api.fda.gov
Boston Scientific LimitedCLONMEL Tipperary, IrelandManufacturer0000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cogentix Medical, Inc.Orangeburg, NY, United StatesManufacturer0000api.fda.gov
Cordica Medical, Inc.Sunrise, FL, United StatesContract manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Dongguan Miqiang Technology Co., LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Ecleris SRLVilla Martelli Buenos Aires, ArgentinaManufacturer, Specification developer0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Enercon TechnologiesGray, ME, United StatesContract manufacturer0000api.fda.gov
Eusa Global LLCMedley, FL, United StatesContract manufacturer0000api.fda.gov
Firefly GlobalBelmont, MA, United StatesManufacturer0000api.fda.gov
Fujifilm CorporationASHIGARAKAMI-GUN Kanagawa, JapanSpecification developer0000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Hanamaki OfficeHANAMAKI-SHI Iwate, JapanManufacturer0000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanManufacturer0000api.fda.gov
Guangdong Optomedic Technologies, Inc.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Hunan Endoso Life Technology Co., LtdXiangTan Hunan, ChinaManufacturer0000api.fda.gov
Ilo Electronic GMBHKaltenkirchen Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler0000api.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. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesSpecification developer0000api.fda.gov
M.I.One Co.,Ltd.Wonju-si Gangwon, South KoreaManufacturer0000api.fda.gov
Machida Endoscope Co., Ltd.Abiko Chiba, JapanManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer0000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Novaalab LLCWilmington, DE, United StatesSpecification developer0000api.fda.gov
Novaprobe Inc.Lansdale, PA, United StatesManufacturer0000api.fda.gov
Oculight Co.,Ltd.Seongnam, South KoreaManufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0000api.fda.gov
Sapi Med S.P.AAlessandria, ItalyManufacturer0000api.fda.gov
Schoelly Fiberoptic, GMBHDENZLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Schoelly-Optix OodPanagyurishte Pazardzhik, BulgariaContract manufacturer0000api.fda.gov
Scivita Medical Technology Co., Ltd.suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Shanghai Seegen Photoelectric Technology Co., LtdShanghai, ChinaManufacturer0000api.fda.gov
Shanghai Seegen Photoelectric Technology Co., LtdShanghai, ChinaManufacturer0000api.fda.gov
Shenzhen Eyco Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Hugemed Medical Technical Development Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Sophway Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Yiguangnian Innovation Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Tangent Endoscopy, LLCCamden, DE, United StatesSpecification developer0000api.fda.gov
Telscope SystemsCastle Hill New South Wales, AustraliaSpecification developer0000api.fda.gov
Tigris Elektronik GMBHBerlin, GermanyContract manufacturer0000api.fda.gov
Vitalcor, Inc.Westmont, IL, United StatesSpecification developer0000api.fda.gov
Xcellance Medical Technologies Pvt. Ltd.Navi Mumbai Maharashtra, IndiaManufacturer0000api.fda.gov

Updated March 16, 2015. 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.