Skip to the page

Data / Medical devices / Staple, Removable (Skin)

Staple, Removable (Skin) (GDT): 64 FDA-registered makers in 11 countries

64 establishments in 11 countries are registered with the FDA to make Staple, Removable (Skin) (product code GDT, Class 1, 21 CFR 878.4760). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on October 21, 1996, and lists 5 recall events (1 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
GDT
Device class
1
Regulation
878.4760
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States21
China18
Mexico6
Taiwan5
Pakistan5
India3
Vietnam2
Dominican Republic1
Israel1
Japan1
Hong Kong1

Makers of Staple, Removable (Skin)

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
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer1April 20, 1990000api.fda.gov
3M Edumex, S.A De C.VCD. JUAREZ Chihuahua, MexicoContract manufacturer, Repackager or relabeler0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesSpecification developer0000api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoContract manufacturer, Exporter to the US, Repackager or relabeler0000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer0000api.fda.gov
B.j.zh.f.panther Medical Equipment Co.,ltdBeijing, ChinaManufacturer0000api.fda.gov
Baisheng Medical Co.,ltd.JIANGMEN Guangdong, ChinaManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Changzhou 3R Medical Device Technology Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Changzhou Lookmed Medical Instrument Co.,ltdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Changzhou Tongchuang Medical Instrument Technology Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Conmed CorporationUtica, NY, United StatesManufacturer0000api.fda.gov
CovidienTIJUANA, B.C. Mexico, MexicoManufacturer0000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer, Specification developer0000api.fda.gov
CovidienPonce, PR, United StatesManufacturer0000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicManufacturer0000api.fda.gov
Design Standards Corp.Charlestown, NH, United StatesContract manufacturer0000api.fda.gov
Ethicon Endo-Surgery, Inc.Cincinnati, OH, United StatesSpecification developer0000api.fda.gov
Ethicon Endo-Surgery, LLCGuaynabo, PR, United StatesSpecification developer0000api.fda.gov
Euroband Bioline LTD.INDUSTRIAL PARK EMEK HEFER Central, IsraelSpecification developer0000api.fda.gov
Finix Industrial Co., Ltd.Chang Hua City Changhua, TaiwanManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Haritex CorporationTaipei City, TaiwanManufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Kitotech Medical IncSeattle, WA, United StatesManufacturer0000api.fda.gov
Lonjyfan Enterprise Corp.New Taipei City, TaiwanManufacturer0000api.fda.gov
Mani, Inc. (head Office)UTSUNOMIYA Tochigi, JapanContract manufacturer, Manufacturer0000api.fda.gov
Marian MonticelloMonticello, IN, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Meril Endo Surgery Pvt. Ltd.Vapi Gujarat, IndiaManufacturer0000api.fda.gov
Modern Medical Equipment Manufacturing (qing Yuan) LtdQING YUAN Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Modern Medical Equipment Manufacturing Ltd.HENG LI, DONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Modern Medical Equipment Manufacturing, Ltd.Kwai Chung, N.T., Hong KongManufacturer0000api.fda.gov
Mani Hanoi Co. LtdThai Nguyen Province, VietnamContract manufacturer0000api.fda.gov
Mani Hanoi Co. Ltd Pho Yen 2 FactoryThai Nguyen Province, VietnamContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer0000api.fda.gov
Ningbo Advan Electrical Co.,ltdCixi City Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Ningbo Greetmed Medical Instruments Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Specification developer0000api.fda.gov
Nypro Healthcare Baja Inc. (Albuquerque)Albuquerque, NM, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Nypro Healthcare Baja Inc. (Torres)Ciudad Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Renovo, Inc.Bend, OR, United StatesReprocessor0000api.fda.gov
Shandong Haidike Medical Products Co., LtdHeze Shandong, ChinaManufacturer0000api.fda.gov
Shaoxing Haitech Medical Products Co., LtdSHAOXING Zhejiang, ChinaManufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
SOLVENTUM US LLC (Apodaca)Apodaca Nuevo Leon, MexicoContract manufacturer, Repackager or relabeler0000api.fda.gov
Suru International Pvt LtdDAHANU Maharashtra, IndiaManufacturer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Solventum US LLCBrookings, SD, United StatesManufacturer0000api.fda.gov
Taiwan Surgical CorporationZhubei City Hsinchu(County), TaiwanManufacturer0000api.fda.gov
Tiger Medical GroupShanghai, ChinaExporter to the US, Specification developer0000api.fda.gov
Touchstone International Medical Science Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Trinity Sterile, Inc.Salisbury, MD, United StatesManufacturer0000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer0000api.fda.gov
Ultra Surgical (pvt.) LtdSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Y.M.K. International Co., Ltd.TAIPEI New Taipei, TaiwanManufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zhejiang Haisheng Medical Device Co., Ltd.Shaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov

Updated October 21, 1996. 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.