Data / Medical devices / United States / MPM Medical
MPM Medical: FDA-registered device maker in Mesquite, TX, United States, 9 510(k) clearances
MPM Medical is registered with the FDA (registration 1646434) in Mesquite, TX, United States. It lists 9 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1646434
- FEI number
- 1000138377
- Address
- 1801 Big Town Blvd Ste 800, Mesquite, TX, United States, 75149
- Owner or operator
- MPM Medical, LLC (10058260)
- Roles
- Specification developer
- First device listed
- August 8, 2018
- Registered through
- 2026
- Brand names listed
- DrySAP, Silver Alginate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | accessdata.fda.gov |
| Oral Wound Dressing | OLR | U | Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Specification developer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Specification developer | accessdata.fda.gov |
| Wound Dressings Containing Topical Analgesics | SEJ | U | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 4, 2024 | K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| November 17, 2023 | K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | FRO | Substantially Equivalent | Roosin Medical Co., Ltd. | accessdata.fda.gov |
| May 1, 2018 | K172554 | LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| July 25, 2017 | K171645 | CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle | KGN | Substantially Equivalent | Strukmyer Medical | accessdata.fda.gov |
| September 16, 2008 | K073019 | SILVERMED ANTIMICROBIAL SILVER HYDROGEL | FRO | Substantially Equivalent | Argentis Biomedical Incorporated | accessdata.fda.gov |
| May 10, 2006 | K060340 | ORAMAGIC PLUS ORAL WOUND RINSE | OLR | Substantially Equivalent | Mpm Medical., Inc. | accessdata.fda.gov |
| March 14, 2003 | K024180 | ORAMAGICRX ORAL WOUND RINSE | OLR | Substantially Equivalent | Mpm Medical., Inc. | accessdata.fda.gov |
| November 1, 2002 | K020540 | REGENECARE WOUND GEL | SEJ | Substantially Equivalent | Mpm Medical., Inc. | accessdata.fda.gov |
| December 18, 1997 | K973693 | AQUA PATCH | MGQ | Substantially Equivalent for Some Indications | Pci Technology | accessdata.fda.gov |
Compare with other makers
- All makers of Oral Wound Dressing
- All makers of Dressing, Wound, Drug
- All makers of Wound Dressings Containing Topical Analgesics
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Dressing, Wound, Occlusive
Updated January 4, 2024. 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.