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Data / Medical devices / Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic (MGQ): 36 FDA-registered makers in 10 countries

36 establishments in 10 countries are registered with the FDA to make Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic (product code MGQ, Class U). 19 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 145 510(k) clearances under this code, the latest on October 16, 2017, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MGQ
Device class
U
Medical specialty
Unknown

Makers by country

CountryMakers
United States25
Italy2
South Korea2
China1
Canada1
Denmark1
Sweden1
India1
France1
Germany1

Makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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
Derma Sciences Nantong IncorporationDEVELOPMENT Jiangsu, ChinaContract manufacturer, Manufacturer4August 13, 1999000api.fda.gov
Amerx Healthcare CorpOldsmar, FL, United StatesRepackager or relabeler, Specification developer2August 12, 1997000api.fda.gov
Derma Sciences Canada, IncTORONTO Ontario, CanadaContract manufacturer, Manufacturer2May 20, 1998000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer2September 20, 2004000api.fda.gov
Fidia Farmaceutici SPAABANO TERME Padova, ItalyManufacturer2September 22, 1998000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer2November 8, 2001000api.fda.gov
Aim Medical IncWestwood, MA, United StatesSpecification developer1October 16, 2017000api.fda.gov
Coloplast A/SHUMLEBAEK Hovedstaden, DenmarkSpecification developer1June 4, 1999000api.fda.gov
Cardinal HealthChicopee, MA, United StatesManufacturer1July 26, 1994000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1July 26, 1994000api.fda.gov
Cardinal HealthAugusta, GA, United StatesManufacturer1July 26, 1994000api.fda.gov
Ferris MFG. Corp.Fort Worth, TX, United StatesManufacturer1September 22, 1998000api.fda.gov
Human Biosciences, Inc.Martinsburg, WV, United StatesManufacturer1December 2, 2002000api.fda.gov
MPM MedicalMesquite, TX, United StatesSpecification developer1December 18, 1997000api.fda.gov
Molnlycke Health Care ABMolndal Vastra Gotaland, SwedenSpecification developer1February 22, 1999000api.fda.gov
Nexgel, Inc.Langhorne, PA, United StatesComplaint file establishment, Specification developer1July 23, 2004000api.fda.gov
Stellen Medical, LLCSaint Paul, MN, United StatesManufacturer1October 2, 2000000api.fda.gov
Swiss-American CDMO,LLCCarrollton, TX, United StatesManufacturer1July 18, 1994000api.fda.gov
Virchow Biotech Pvt. Ltd.Hyderabad Telangana, IndiaManufacturer1November 8, 2001000api.fda.gov
3-D Matrix Europe SASCaluire et Cuire Rhone, FranceSpecification developer0000api.fda.gov
3-D Matrix, Inc.Newton, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Biokosmes SRLBosisio Parini,Lecco, ItalyContract manufacturer0000api.fda.gov
Biomed Laboratories LLCDallas, TX, United StatesContract manufacturer0000api.fda.gov
Biostech Co., Ltd.Eumseong-gun Chungbuk, South KoreaContract manufacturer0000api.fda.gov
CG Converting And Packaging, LLCGranbury, TX, United StatesContract manufacturer0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer0000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer0000api.fda.gov
Forward Science Technologies LLCHouston, TX, United StatesManufacturer0000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesManufacturer0000api.fda.gov
Lindo ManufacturingSwansea, MA, United StatesContract manufacturer0000api.fda.gov
Medline Industries, LPNorth Mankato, MN, United StatesContract manufacturer0000api.fda.gov
Pharmpur GMBHKonigsbrunn, Bavaria, GermanyContract manufacturer0000api.fda.gov
Primus Pharmaceuticals, Inc.Scottsdale, AZ, United StatesSpecification developer0000api.fda.gov
SPAN PACKAGING SERVICES d.b.a. MULTI-PACK SOLUTIONSGreenville, SC, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Sterigenics US LLCFort Worth, TX, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
TBM CorporationBuk-gu, Gwangju, South KoreaManufacturer0000api.fda.gov

Updated October 16, 2017. 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.