Skip to the page
Get started – free

Data / Medical devices / Holder, Camera, Surgical

Holder, Camera, Surgical (FXR): 20 FDA-registered makers in 9 countries

20 establishments in 9 countries are registered with the FDA to make Holder, Camera, Surgical (product code FXR, Class 1, 21 CFR 878.4160). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on February 21, 1985, and lists 0 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
FXR
Device class
1
Regulation
878.4160
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States7
France3
Germany2
Pakistan2
China2
Poland1
Mexico1
Sweden1
Canada1

Makers of Holder, Camera, Surgical

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
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.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
Fluoptics SASGRENOBLE Auvergne-Rhone-Alpes, FranceComplaint file establishment, Manufacturer0000api.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
Heinrich Medizintechnik GMBHStuttgart Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Lsi Solutions Inc.Victor, NY, United StatesManufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesSpecification developer0000api.fda.gov
Maquet S.A.S.ARDON, ORLEANS CEDEX 2 Loiret, FranceManufacturer0000api.fda.gov
Neko Health ABSolna, SwedenExporter to the US, Manufacturer0000api.fda.gov
Novadaq Technologies ULCBurnaby British Columbia, CanadaExporter to the US, Specification developer0000api.fda.gov
Pixee MedicalBesancon Doubs, FranceManufacturer0000api.fda.gov
Tedan Surgical Innovations, Inc.Sugar Land, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov

Updated February 21, 1985. 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.