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Data / Medical devices / Plastic Surgery And Accessories Kit

Plastic Surgery And Accessories Kit (FTN): 25 FDA-registered makers in 10 countries

25 establishments in 10 countries are registered with the FDA to make Plastic Surgery And Accessories Kit (product code FTN, Class 1, 21 CFR 878.3925). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 40 recall events (3 Class I). FDA data exported November 2, 2026.

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Product code
FTN
Device class
1
Regulation
878.3925
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States12
Mexico4
China2
France1
South Korea1
Israel1
Pakistan1
Honduras1
India1
Brazil1

Makers of Plastic Surgery And Accessories Kit

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
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Aesthetic GroupPuiseux Le Hauberger Oise, FranceManufacturer0000api.fda.gov
BECON MEDICAL Ltd.Batavia, IL, United StatesSpecification developer0000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Dongguan Shin Yi Healthcare Products FactoryDONG GUAN CITY Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Ecm Bio Lab Co., Ltd.Seoul, South KoreaManufacturer, Repackager or relabeler0000api.fda.gov
EarGear LLCEden Prairie, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Euroband Bioline LTD.INDUSTRIAL PARK EMEK HEFER Central, IsraelManufacturer, Specification developer0000api.fda.gov
Gid Bio Inc.Louisville, CO, United StatesSpecification developer0000api.fda.gov
Gri Medical & Electronic Technology Co., Ltd.JIAXING Zhejiang, ChinaManufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Invenio Alternate Care Solutions, LLCPeachtree Corners, GA, United StatesContract manufacturer0000api.fda.gov
Ipax, Inc.Englewood, CO, United StatesContract manufacturer0000api.fda.gov
Lipomax MFG., Inc.Brea, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Medical Action Industries, Inc. 306Arden, NC, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Meditec DevicesVasai(E), Thane, Maharashtra, IndiaContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - LaredoLaredo, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medline Industries, LP - SPTWaukegan, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medline Industries, LP - Mexicali (MXC)Mexicali Baja California, MexicoContract sterilizer, Manufacturer0000api.fda.gov
Medline Soluciones MedicasNuevo Laredo Tamaulipas, MexicoManufacturer0000api.fda.gov
Neoortho Produtos Ortopedicos S/ACuritiba Parana, BrazilManufacturer0000api.fda.gov
Productos Medline S.A. De C.V.NUEVO LAREDO Tamaulipas, MexicoManufacturer0000api.fda.gov
Sklar CorporationMalvern, PA, United StatesSpecification developer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov

Updated November 2, 2026. 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.