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Data / Medical devices / Camera, Still, Surgical

Camera, Still, Surgical (FTT): 12 FDA-registered makers in 6 countries

12 establishments in 6 countries are registered with the FDA to make Camera, Still, Surgical (product code FTT, 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 1 510(k) clearance under this code, the latest on December 15, 1982, 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.

Product code
FTT
Device class
1
Regulation
878.4160
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
South Korea4
United States3
Taiwan2
China1
Sweden1
Germany1

Makers of Camera, Still, 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
Altek Biotechnology CorporationHsinchu Hsinchu(City), TaiwanComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Altek Medical (kunshan) limitedKunshan Free Trade Zone Jiangsu, ChinaContract manufacturer0000api.fda.gov
Canfield Scientific, Inc.Parsippany, NJ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Lumo Imaging LLCPotomac, MD, United StatesComplaint file establishment, Specification developer0000api.fda.gov
M.I.One Co.,Ltd.Wonju-si Gangwon, South KoreaManufacturer0000api.fda.gov
Medimaging Integrated Solution Inc.Hsinchu Hsinchu(City), TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Morpheus Co., Ltd.Yongin Gyeonggi, South KoreaManufacturer0000api.fda.gov
Neko Health ABSolna, SwedenExporter to the US, Manufacturer0000api.fda.gov
NTL Healthcare Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Psi Plus Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Rudolf Riester GMBHJUNGINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated December 15, 1982. 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.