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Data / Medical devices / Accessories, Photographic, For Endoscope (Exclude Light Sources)

Accessories, Photographic, For Endoscope (Exclude Light Sources) (FEM): 52 FDA-registered makers in 12 countries

52 establishments in 12 countries are registered with the FDA to make Accessories, Photographic, For Endoscope (Exclude Light Sources) (product code FEM, Class 1, 21 CFR 876.1500). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on October 28, 1994, and lists 4 recall events (0 Class I). FDA data exported November 2, 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
FEM
Device class
1
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States20
Germany8
Japan8
China8
Denmark1
Taiwan1
Mexico1
United Kingdom1
Switzerland1
South Korea1
Czechia1
Italy1

Makers of Accessories, Photographic, For Endoscope (Exclude Light Sources)

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, GermanyManufacturer0000api.fda.gov
Ars Co., Ltd.Kofu Yamanashi, JapanManufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ambu A/SBallerup Hovedstaden, DenmarkSpecification developer0000api.fda.gov
Anhui Shiyin Photoelectric Instrument Co., Ltd.Suzhou Anhui, ChinaManufacturer, Specification developer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Beijing Fanxing Guangdian Medical Treatment Equipment Co LtdBeijing, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer0000api.fda.gov
Britemed Technology Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Clarus Medical, LLC.Minneapolis, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Endocraft LLC.Newton, MA, United StatesManufacturer0000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanSpecification 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
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionKURIHARA-SHI Miyagi, JapanExporter to the US, Manufacturer0000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionAkishima-shi Tokyo, JapanComplaint file establishment, Specification developer0000api.fda.gov
Hunan Vathin Medical Instrument Co., Ltd.Xiangtan Hunan, ChinaManufacturer0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Innomed, Inc.Savannah, GA, United StatesSpecification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu Mole Electronic Technology Co., LtdXuzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Karl Storz Imaging, Inc.Goleta, CA, United StatesContract manufacturer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
KEYMED (Medical & Industrial Equipment) LtdSOUTHEND-ON-SEA Essex, United KingdomManufacturer, Specification developer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesSpecification developer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
MediThinQ Co., Ltd.Seongnam Gyeonggi, South KoreaManufacturer0000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer0000api.fda.gov
Novanta Medical S.R.O.Prelouc Pardubicky Kraj, CzechiaManufacturer0000api.fda.gov
Novanta Medical GmbHLUDWIGSSTADT Bavaria, GermanyManufacturer0000api.fda.gov
Novanta Medical GmbHBerlin, GermanySpecification developer0000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Precision Optics Corp.Gardner, MA, United StatesContract manufacturer0000api.fda.gov
Qingdao O-Mec Medical Technology Co., Ltd.Qingdao Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0000api.fda.gov
Santa Barbara Imaging SystemsGoleta, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Sapi Med S.P.AAlessandria, ItalyManufacturer0000api.fda.gov
Shenzhen Besdata Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Hugemed Medical Technical Development Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shirakawa Olympus Co., Ltd.NISHISHIRAKAWA-GUN Fukushima, JapanManufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Transamerican Technologies InternationalSan Ramon, CA, United StatesManufacturer0000api.fda.gov
Zhongshan Wesee Meditech Co., Ltd.Zhongshan Guangdong, ChinaManufacturer0000api.fda.gov
asap endoscopic products GmbHUmkirch Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated October 28, 1994. 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.