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
| Country | Makers |
|---|---|
| United States | 25 |
| Italy | 2 |
| South Korea | 2 |
| China | 1 |
| Canada | 1 |
| Denmark | 1 |
| Sweden | 1 |
| India | 1 |
| France | 1 |
| Germany | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Derma Sciences Nantong Incorporation | DEVELOPMENT Jiangsu, China | Contract manufacturer, Manufacturer | 4 | August 13, 1999 | 0 | 0 | 0 | api.fda.gov |
| Amerx Healthcare Corp | Oldsmar, FL, United States | Repackager or relabeler, Specification developer | 2 | August 12, 1997 | 0 | 0 | 0 | api.fda.gov |
| Derma Sciences Canada, Inc | TORONTO Ontario, Canada | Contract manufacturer, Manufacturer | 2 | May 20, 1998 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 2 | September 20, 2004 | 0 | 0 | 0 | api.fda.gov |
| Fidia Farmaceutici SPA | ABANO TERME Padova, Italy | Manufacturer | 2 | September 22, 1998 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 2 | November 8, 2001 | 0 | 0 | 0 | api.fda.gov |
| Aim Medical Inc | Westwood, MA, United States | Specification developer | 1 | October 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Coloplast A/S | HUMLEBAEK Hovedstaden, Denmark | Specification developer | 1 | June 4, 1999 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Chicopee, MA, United States | Manufacturer | 1 | July 26, 1994 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | July 26, 1994 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Augusta, GA, United States | Manufacturer | 1 | July 26, 1994 | 0 | 0 | 0 | api.fda.gov |
| Ferris MFG. Corp. | Fort Worth, TX, United States | Manufacturer | 1 | September 22, 1998 | 0 | 0 | 0 | api.fda.gov |
| Human Biosciences, Inc. | Martinsburg, WV, United States | Manufacturer | 1 | December 2, 2002 | 0 | 0 | 0 | api.fda.gov |
| MPM Medical | Mesquite, TX, United States | Specification developer | 1 | December 18, 1997 | 0 | 0 | 0 | api.fda.gov |
| Molnlycke Health Care AB | Molndal Vastra Gotaland, Sweden | Specification developer | 1 | February 22, 1999 | 0 | 0 | 0 | api.fda.gov |
| Nexgel, Inc. | Langhorne, PA, United States | Complaint file establishment, Specification developer | 1 | July 23, 2004 | 0 | 0 | 0 | api.fda.gov |
| Stellen Medical, LLC | Saint Paul, MN, United States | Manufacturer | 1 | October 2, 2000 | 0 | 0 | 0 | api.fda.gov |
| Swiss-American CDMO,LLC | Carrollton, TX, United States | Manufacturer | 1 | July 18, 1994 | 0 | 0 | 0 | api.fda.gov |
| Virchow Biotech Pvt. Ltd. | Hyderabad Telangana, India | Manufacturer | 1 | November 8, 2001 | 0 | 0 | 0 | api.fda.gov |
| 3-D Matrix Europe SAS | Caluire et Cuire Rhone, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| 3-D Matrix, Inc. | Newton, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biokosmes SRL | Bosisio Parini,Lecco, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomed Laboratories LLC | Dallas, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biostech Co., Ltd. | Eumseong-gun Chungbuk, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CG Converting And Packaging, LLC | Granbury, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Maynardville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forward Science Technologies LLC | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inter-Med, Inc. | Racine, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lindo Manufacturing | Swansea, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP | North Mankato, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pharmpur GMBH | Konigsbrunn, Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primus Pharmaceuticals, Inc. | Scottsdale, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SPAN PACKAGING SERVICES d.b.a. MULTI-PACK SOLUTIONS | Greenville, SC, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics US LLC | Fort Worth, TX, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| TBM Corporation | Buk-gu, Gwangju, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.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.