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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

CountryMakers
United States14
Pakistan7
Germany4
China4
South Korea2
Mexico2
Israel1
Costa Rica1
Turkey1
Italy1
Taiwan1
Switzerland1
India1
United Kingdom1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
4 Med Ltd.Lavon Northern, IsraelManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Design Standards Corp.Charlestown, NH, United StatesContract manufacturer0000api.fda.gov
DmedSeongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Establishment Labs S.A.Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Exsurco Medical, Inc.Wakeman, OH, United StatesManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Global Biyomedikal Saglik Hizmetleri Sanayi Ve Ticaret Limited SirketiBAHCELIEVLER Istanbul, TurkeyManufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Henan Huibo Medical Co., LtdNanyang City Henan, ChinaManufacturer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Human Brain Wave SRLTorino, ItalyManufacturer0000api.fda.gov
Integra Lifesciences CorporationCincinnati, OH, United StatesSpecification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Jiangsu MJD Medical Technology Co.,ltd.TAIZHOU Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kapp Surgical GMBHDUERBHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
L&K Biomed Co.,ltd.Yongin-SI Gyeonggi, South KoreaManufacturer0000api.fda.gov
Lenox-Maclaren Surgical Corp.Louisville, CO, United StatesManufacturer0000api.fda.gov
Nextcon InternationalSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
North Eos Industries, Inc.Taichung City, TaiwanManufacturer0000api.fda.gov
Nouvag AGGOLDACH Sankt Gallen, SwitzerlandManufacturer0000api.fda.gov
Ribbel International Ltd.SONEPAT Haryana, IndiaManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
SIGN Fracture Care InternationalRichland, WA, United StatesManufacturer0000api.fda.gov
Sitec (pvt.) Ltd.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
Swann Morton, Ltd.Sheffield, United KingdomManufacturer0000api.fda.gov
Stellen Medical, LLCSaint Paul, MN, United StatesManufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Viant Mexicana de Servicios, S. de R.L. de C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Yafho Bio-Technology Co., Ltd.GUANGZHOU Guangdong, ChinaManufacturer0000api.fda.gov
Zimmer Surgical, Inc.Dover, OH, United StatesManufacturer0010api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0010api.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.