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
| Country | Makers |
|---|---|
| United States | 21 |
| China | 18 |
| Mexico | 6 |
| Taiwan | 5 |
| Pakistan | 5 |
| India | 3 |
| Vietnam | 2 |
| Dominican Republic | 1 |
| Israel | 1 |
| Japan | 1 |
| Hong Kong | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 1 | April 20, 1990 | 0 | 0 | 0 | api.fda.gov |
| 3M Edumex, S.A De C.V | CD. JUAREZ Chihuahua, Mexico | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASP Global, LLC | Austell, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Contract manufacturer, Exporter to the US, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B.j.zh.f.panther Medical Equipment Co.,ltd | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baisheng Medical Co.,ltd. | JIANGMEN Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou 3R Medical Device Technology Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Lookmed Medical Instrument Co.,ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Tongchuang Medical Instrument Technology Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conmed Corporation | Utica, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | North Haven, CT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | Ponce, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Design Standards Corp. | Charlestown, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon Endo-Surgery, Inc. | Cincinnati, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon Endo-Surgery, LLC | Guaynabo, PR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroband Bioline LTD. | INDUSTRIAL PARK EMEK HEFER Central, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Finix Industrial Co., Ltd. | Chang Hua City Changhua, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haritex Corporation | Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hexamed Pvt Ltd | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hilbro International (pvt) Limited | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kitotech Medical Inc | Seattle, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lonjyfan Enterprise Corp. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani, Inc. (head Office) | UTSUNOMIYA Tochigi, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marian Monticello | Monticello, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meril Endo Surgery Pvt. Ltd. | Vapi Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing (qing Yuan) Ltd | QING YUAN Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing Ltd. | HENG LI, DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing, Ltd. | Kwai Chung, N.T., Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani Hanoi Co. Ltd | Thai Nguyen Province, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani Hanoi Co. Ltd Pho Yen 2 Factory | Thai Nguyen Province, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Advan Electrical Co.,ltd | Cixi City Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo Zhejiang, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Healthcare Baja Inc. (Albuquerque) | Albuquerque, NM, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Healthcare Baja Inc. (Torres) | Ciudad Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Renovo, Inc. | Bend, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Haidike Medical Products Co., Ltd | Heze Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Haitech Medical Products Co., Ltd | SHAOXING Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SOLVENTUM US LLC (Apodaca) | Apodaca Nuevo Leon, Mexico | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suru International Pvt Ltd | DAHANU Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | Brookings, SD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taiwan Surgical Corporation | Zhubei City Hsinchu(County), Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiger Medical Group | Shanghai, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Touchstone International Medical Science Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trinity Sterile, Inc. | Salisbury, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultra Surgical (pvt.) Ltd | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Y.M.K. International Co., Ltd. | TAIPEI New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zain's Medical Image | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.