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Data / Medical devices / Tape, Camera, Surgical

Tape, Camera, Surgical (FXN): 24 FDA-registered makers in 8 countries

24 establishments in 8 countries are registered with the FDA to make Tape, Camera, Surgical (product code FXN, Class 1, 21 CFR 878.4160). 1 of them has 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 December 11, 2013, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

CountryMakers
United States13
China3
Canada3
India1
Belgium1
Cambodia1
Israel1
Taiwan1

Makers of Tape, 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
WoundVision, LLCIndianapolis, IN, United StatesManufacturer1December 11, 2013000api.fda.gov
Adiuvo Diagnostics Private LimitedVisakhapatnam Andhra Pradesh, IndiaContract manufacturer0000api.fda.gov
Am8 Technologies, LLCSt Petersburg, FL, United StatesManufacturer0000api.fda.gov
Changzhou Major Medical Products Co., Ltd.CHANGZHOU Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dermatoo SRLEmbourg Liege, BelgiumManufacturer0000api.fda.gov
Dongguan Hosscom Plastic Technology Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Ekare Inc.Fairfax, VA, United StatesManufacturer0000api.fda.gov
Epic Systems CorporationVerona, WI, United StatesManufacturer0000api.fda.gov
Garrett Heilbrun Technology Partners, LLC Dba Cobalt Product SolutionsPlano, TX, United StatesContract manufacturer0000api.fda.gov
Guangdong Tidakang Medical Technology Co., LtdZhongShan City Guangdong, ChinaManufacturer0000api.fda.gov
Guardmed Healthcare KH Co., Ltd.Bati District Takeo, CambodiaExporter to the US, Manufacturer0000api.fda.gov
Healthy.io Ltd.Tel Aviv-Yafo, IsraelManufacturer0000api.fda.gov
Kent Imaging IncCalgary Alberta, CanadaSpecification developer0000api.fda.gov
Medimaging Integrated Solution Inc.Hsinchu Hsinchu(City), TaiwanExporter to the US, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Moleculight Inc.TORONTO Ontario, CanadaComplaint file establishment, Manufacturer0000api.fda.gov
Med-Compliance IQ IncColumbus, OH, United StatesManufacturer0000api.fda.gov
Net Health Systems, Inc.Pittsburgh, PA, United StatesManufacturer0000api.fda.gov
Parable Health, Inc.Las Vegas, NV, United StatesManufacturer0000api.fda.gov
Spectral MD, Inc.Dallas, TX, United StatesManufacturer for export0000api.fda.gov
Swift MedicalToronto Ontario, CanadaManufacturer0000api.fda.gov
TRUE-SEE SYSTEMS, IncNew Orleans, LA, United StatesSpecification developer0000api.fda.gov
Tissue Health Plus, LLCFort Worth, TX, United StatesManufacturer0000api.fda.gov
Woundmatrix, Inc.Chadds Ford, PA, United StatesManufacturer0000api.fda.gov

Updated December 11, 2013. 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.