Data / Medical devices / Expander, Surgical, Skin Graft
Expander, Surgical, Skin Graft (FZW): 41 FDA-registered makers in 14 countries
41 establishments in 14 countries are registered with the FDA to make Expander, Surgical, Skin Graft (product code FZW, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on May 2, 2008, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FZW
- Device class
- 1
- Regulation
- 878.4800
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 14 |
| Pakistan | 7 |
| Germany | 4 |
| China | 4 |
| South Korea | 2 |
| Mexico | 2 |
| Israel | 1 |
| Costa Rica | 1 |
| Turkey | 1 |
| Italy | 1 |
| Taiwan | 1 |
| Switzerland | 1 |
| India | 1 |
| United Kingdom | 1 |
Makers of Expander, Surgical, Skin Graft
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 |
|---|---|---|---|---|---|---|---|---|
| 4 Med Ltd. | Lavon Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Design Standards Corp. | Charlestown, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dmed | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Establishment Labs S.A. | Coyol Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exsurco Medical, Inc. | Wakeman, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garish Apparels | Wazirabad Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Biyomedikal Saglik Hizmetleri Sanayi Ve Ticaret Limited Sirketi | BAHCELIEVLER Istanbul, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Huibo Medical Co., Ltd | Nanyang City Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hive International Pvt Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Human Brain Wave SRL | Torino, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Lifesciences Corporation | Cincinnati, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu MJD Medical Technology Co.,ltd. | TAIZHOU Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kapp Surgical GMBH | DUERBHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L&K Biomed Co.,ltd. | Yongin-SI Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lenox-Maclaren Surgical Corp. | Louisville, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextcon International | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Eos Industries, Inc. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nouvag AG | GOLDACH Sankt Gallen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ribbel International Ltd. | SONEPAT Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Medical Instruments (group) Ltd. Corp. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SIGN Fracture Care International | Richland, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sitec (pvt.) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicon Pvt Ltd | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Swann Morton, Ltd. | Sheffield, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stellen Medical, LLC | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Mexicana de Servicios, S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Win Wings Corp. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yafho Bio-Technology Co., Ltd. | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Surgical, Inc. | Dover, OH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Zimmer, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov |
Updated May 2, 2008. 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.