Data / Medical devices / Dress, Surgical

Dress, Surgical (FYE): 90 FDA-registered makers in 16 countries

Name: FDA-registered makers of Dress, Surgical
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

90 establishments in 16 countries are registered with the FDA to make Dress, Surgical (product code FYE, Class 1, 21 CFR 878.4040). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on April 11, 1994, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: FYE
Device class: 1
Regulation: 878.4040
Medical specialty: General, Plastic Surgery

Makers by country

Country	Makers
China	60
United States	7
Mexico	4
Pakistan	3
Vietnam	2
Canada	2
Malaysia	2
Cambodia	2
India	1
South Korea	1
Ireland	1
El Salvador	1
Egypt	1
Bangladesh	1
Indonesia	1
Peru	1

Makers of Dress, 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.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	1	May 9, 1991	1	api.fda.gov
Acme Enterprises	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
American Dawn Inc.	Compton, CA, United States	Specification developer	0		0	api.fda.gov
An Lanh Investment And Trading Company Limited	Thanh Nam Ward Ninh Binh, Vietnam	Exporter to the US, Manufacturer	0		0	api.fda.gov
Anhui Ares Medical Technology Co.,ltd.	Tianchang Anhui, China	Manufacturer	0		0	api.fda.gov
Anzen Health	Chicago, IL, United States	Specification developer	0		0	api.fda.gov
Apothecaries Sundries MFG Pvt Ltd	GURUGRAM Haryana, India	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Beijing ZKSK Technology Co., Ltd.	beijing, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Berkley Medical Resources, Inc.	Smithfield, PA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	api.fda.gov
Biomed Plastics Co.	Taicang, Jiangsu, China	Specification developer	0		0	api.fda.gov
Boen Healthcare Co., Ltd.	Suzhou Jiangsu, China	Exporter to the US, Specification developer	0		0	api.fda.gov
Changzhou 3R Medical Device Technology Co., Ltd.	Changzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Crosstex International	Rush, NY, United States	Manufacturer	0		0	api.fda.gov
Dasol International Ltd.	Siheung-Si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Specification developer	0		0	api.fda.gov
Ecollink Non-Woven Company Limited	Hongkong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Evereast Medical Products Group Co., Ltd	Changyuan City Henan, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Fesun Shanghai Co., Ltd.	shanghai, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
George Courey Inc	Montreal Quebec, Canada	Complaint file establishment, Exporter to the US, Specification developer	0		0	api.fda.gov
Guang Xi Fulaiming Biopharmaceutics Co., Ltd.	Nanning Guangxi, China	Manufacturer	0		0	api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltd	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Gushi priMED Medical Products Manufacturing Co., Ltd.	Gushi County Henan, China	Contract manufacturer	0		0	api.fda.gov
Hangzhou Rollmed Co.,ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Hefei Mlush Sanitary Products Co.,ltd	Hefei Anhui, China	Manufacturer	0		0	api.fda.gov
Henan Joinkona Medical Products Stock Co.,ltd	Pingdingshan Henan, China	Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor	0		0	api.fda.gov
Henan Robestain Medical Products Co., Ltd.	Changyuan Henan, China	Manufacturer	0		0	api.fda.gov
Hubei Feiteng Protective Products Co.,ltd	Xiantao Hubei, China	Manufacturer	0		0	api.fda.gov
Hubei Kangcheng Non-Woven Co., Ltd	XIANTAO Hebei, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hubei Weikang Protective Products Co.ltd	XIANTAO Hubei, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Hubei Xianmeng Health Protection Commodity.,ltd	Xiantao Hubei, China	Manufacturer	0		0	api.fda.gov
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan City Hubei, China	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Icat S.A. De C.V.	San Salvador, El Salvador	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Jiangsu Kangjian Medical Apparatus Co., Ltd.	JIANGYAN Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jiangsu Medplus Non-Woven Manufacturer Co.,ltd.	Siyang Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jingxin Group (M) Sdn Bhd	Kulai Johor, Malaysia	Manufacturer	0		0	api.fda.gov
Jingxin Group (M) Sdn Bhd	Kulai Johor, Malaysia	Manufacturer	0		0	api.fda.gov
Jinhua Jingdi Medical Supplies Co.,ltd	Jinhua Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
JM Medical Co., Ltd.	Liaocheng Shandong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Jiangsu Guangda Medical Material Group Co., Ltd.	Haian Jiangsu, China	Manufacturer	0		0	api.fda.gov
Kunshan Jiehong Nonwoven Product Co., Ltd.	KUNSHAN CITY Jiangsu, China	Manufacturer	0		0	api.fda.gov
Med-Linket Corp	Alhambra, CA, United States	Manufacturer	0		0	api.fda.gov
Medtecs (cambodia) Corp. Limited	Srok Kampong Siem Kampong Cham, Cambodia	Exporter to the US, Manufacturer	0		0	api.fda.gov
Miracle Medical Industries	El Obour City Al Qahirah, Egypt	Exporter to the US, Manufacturer	0		0	api.fda.gov
Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, Mexico	Contract sterilizer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Medline Soluciones Medicas	Nuevo Laredo Tamaulipas, Mexico	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Nanning Tecbod Biological Technology Co.,ltd	Nanning Guangxi, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Operating Theatre Medical Bangladesh Company Limited	Kaliakair Gazipur, Bangladesh	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Primed Liyang Medical Products Manufacturing Co., Ltd.	Liyang Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Primed Medical Products Inc.	Edmonton Alberta, Canada	Specification developer	0		0	api.fda.gov
Productos Medline S.A. De C.V.	NUEVO LAREDO Tamaulipas, Mexico	Manufacturer	0		0	api.fda.gov
PT. Jayamas Wellong Medical	Kab. Jombang Jawa Timur, Indonesia	Manufacturer	0		0	api.fda.gov
Principle & Will Biotech (Pinghu) Co., Ltd.	Pinghu City Zhejiang, China	Manufacturer	0		0	api.fda.gov
Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation	Dien Ban Bac Ward Da Nang, Vietnam	Manufacturer	0		0	api.fda.gov
R & G Seguridad E Higiene Industrial S.A.C.	VENTANILLA Lima(Province), Peru	Manufacturer	0		0	api.fda.gov
Samaritan Textile (cambodia) Co., Ltd.	Phnom Penh, Cambodia	Manufacturer	0		0	api.fda.gov
Shandong Aishule Hygiene Products Co., Ltd	Linyi Shandong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Hengdasheng Technology Co., Ltd	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Med-Link Electronics Tech Co.,ltd	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shijiazhuang Runyi Medical Device Technology Co.,ltd.	Shijiazhuang Hebei, China	Manufacturer	0		0	api.fda.gov
Shunde Lucas Industries	Foshan City Guangdong, China	Manufacturer	0		0	api.fda.gov
Sultex Industries	karachi Sindh, Pakistan	Manufacturer	0		0	api.fda.gov
Suzhou Pac-Dent Technology Co., Ltd	SUZHOU CITY Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
TF New Material Sci And Tec Co.,ltd	Huainan Anhui, China	Manufacturer	0		0	api.fda.gov
Tissue Protective Products Co., Ltd	tianmen Hubei, China	Manufacturer	0		0	api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.	MEXICALI Baja California, Mexico	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Two One Two New York, Inc.	Edgewood, NY, United States	Manufacturer	0		0	api.fda.gov
U.S. Pacific Nonwovens Technology (Dongguan) Ltd	Dongguan City Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
United towel Exporters	Karachi Sindh, Pakistan	Manufacturer	0		0	api.fda.gov
Weihai Dishang Medical Technology Co.,ltd	Weihai Shandong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Weihai Kangzhou Biotechnology Engineering Co., Ltd.	Weihai Shandong, China	Manufacturer	0		0	api.fda.gov
Wuhan Huaxin Nonwoven Co., Ltd	Wuhan Hubei, China	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Wuhan Lucky Star Non Woven Products Co Ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Wuhan Raytex Protection Co., Ltd	Wuhan Hubei, China	Manufacturer	0		0	api.fda.gov
Weihai Hongyu Nonwoven Fabric Products Co.,Ltd	Weihai Shandong, China	Manufacturer	0		0	api.fda.gov
Weihai Kangzheng Medical Equipments Technology Co.,Ltd	weihai Shandong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Wuhan Bestar Industry Co.,Ltd	Wuhan Hubei, China	Manufacturer	0		0	api.fda.gov
Xiamen Hoy Plastic Industrial Co.,ltd	Xiamen Fujian, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Xiamen Probtain Medical Technology Co.,ltd	Xiamen Fujian, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Xianning Full Guard Medical Products Co.,ltd	Xianning City Hubei, China	Manufacturer	0		0	api.fda.gov
Xiantao Chenguang Protection Commodity Co Ltd	XIANTAO Hubei, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Xiantao Daoqi Plastic Co., Ltd.	Xiantao Hubei, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Xiantao Generalcare Protection Products Co.,ltd	Xiantao City Hubei, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Xiantao Maosheng Plastic Products Co., Ltd.	XIANTAO CITY Hubei, China	Manufacturer	0		0	api.fda.gov
Xiantao TSW Protective Products Co., Ltd.	Xiantao Hubei, China	Manufacturer	0		0	api.fda.gov
Xiantao Zhibo Nonwoven Products Co.,ltd	Xiantao City Hubei, China	Manufacturer	0		0	api.fda.gov
Yiwu Ruoxuan Garment Co.,ltd	Jinhua Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhejiang Aoki Medical Dressing Co., Ltd	Wenzhou Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltd	Ningbo Zhejiang, China	Manufacturer	0		0	api.fda.gov
ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, China	Manufacturer	0		0	api.fda.gov
Zhejiang Wellong Medical Technology Co., Ltd	Huzhou City Zhejiang, China	Manufacturer	0		0	api.fda.gov

Updated April 11, 1994. 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.