Data / Medical devices / Prosthesis, Breast, External, No Adhesive

Prosthesis, Breast, External, No Adhesive (NOJ): 17 FDA-registered makers in 11 countries

Name: FDA-registered makers of Prosthesis, Breast, External, No Adhesive
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 11 countries are registered with the FDA to make Prosthesis, Breast, External, No Adhesive (product code NOJ, Class 1, 21 CFR 878.3800). 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: NOJ
Device class: 1
Regulation: 878.3800
Medical specialty: General, Plastic Surgery

Makers by country

Country	Makers
United States	4
China	2
Germany	2
Turkey	2
Nicaragua	1
Taiwan	1
Brazil	1
Vietnam	1
Canada	1
Ireland	1
India	1

Makers of Prosthesis, Breast, External, No Adhesive

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.

Maker	Location	Role	Source
A And T Nicaragua, S.A.	Masaya, Nicaragua	Contract manufacturer	api.fda.gov
Allmay Bodywear (shenzhen) Co., Ltd	Shenzhen Guangdong, China	Contract manufacturer	api.fda.gov
American Breast Care LP	Marietta, GA, United States	Manufacturer	api.fda.gov
Amoena Medizin-Orthopadie-Technik GMBH	Raubling, Bavaria, Germany	Manufacturer	api.fda.gov
Auggie, Inc.	Denver, CO, United States	Repackager or relabeler, Specification developer	api.fda.gov
Dongguan Lanke Silicone Technology Co., Ltd.	DONGGUAN Guangdong, China	Contract manufacturer, Manufacturer	api.fda.gov
Jing Yun Plastic Co., Ltd.	New Taipei City, Taiwan	Manufacturer	api.fda.gov
Ortho Pauher Ind. Com. E Dist. Ltda	Recife Pernambuco, Brazil	Exporter to the US, Foreign private label distributor, Manufacturer	api.fda.gov
Precision Fulfillment Solutions	Waco, TX, United States	Manufacturer	api.fda.gov
Regina Miracle International (viet Nam) Co., Ltd	Haiphong Hai Phong, Vietnam	Manufacturer	api.fda.gov
The Marena Group, LLC.	Lawrenceville, GA, United States	Manufacturer	api.fda.gov
Thuasne Deutschland GMBH	Burgwedel Lower Saxony, Germany	Manufacturer	api.fda.gov
Trulife Limited	TRENTON Ontario, Canada	Manufacturer	api.fda.gov
Trulife Ltd.	DUBLIN 24 Dublin(County), Ireland	Manufacturer	api.fda.gov
Tynor Orthotics (P) Ltd.	Mohali Punjab, India	Manufacturer	api.fda.gov
Vizor Ortopedi Medikal Urunleri Pazarlama Ithalat Ihracat Sanayi Ve Ticaret Ltd Sti	KUCUKCEKMECE Istanbul, Turkey	Contract manufacturer, Manufacturer	api.fda.gov
Variteks Ortopedi Sanayi A.S.	Catalca Istanbul, Turkey	Contract manufacturer, Exporter to the US, Manufacturer	api.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.