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Data / Medical devices / Tape, Orthopedic

Tape, Orthopedic (HXT): 21 FDA-registered makers in 7 countries

21 establishments in 7 countries are registered with the FDA to make Tape, Orthopedic (product code HXT, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HXT
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States9
China6
Switzerland2
Germany1
Thailand1
South Korea1
India1

Makers of Tape, Orthopedic

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
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Baechler Feintech AGHoelstein Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
Biviax GMBH & Co KGDortmund North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
Changzhou DL Medical & Health Equipment Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
InnovizeNorth Oaks, MN, United StatesContract manufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
Pharmacare LimitedBANGKOK Krung Thep Maha Nakhon, ThailandContract manufacturer, Manufacturer0000api.fda.gov
Prime Medical, Inc.HWASEONG-SI Gyeonggi, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Prime Medica Promotion Private LimitedVadodara Gujarat, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Richardson Products, Inc.Frankfort, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Shaanxi Ansen Medical Technology Development Co.,ltd.Xi'an Shaanxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Stetrix Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
The Super Patch Company Ltd LLCHollywood, FL, United StatesSpecification developer0000api.fda.gov
Yancheng Trancom First Aid Supplies Industrial Co., LtdYangcheng Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zimmer GMBHWINTERTHUR Zurich, SwitzerlandManufacturer0000api.fda.gov

Updated November 2, 2026. 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.