Data / Medical devices / United States / Advanced Medical Associates, LLC
Advanced Medical Associates, LLC: FDA-registered device maker in Dallas, TX, United States, 3 510(k) clearances
Advanced Medical Associates, LLC is registered with the FDA (registration 3010763707) in Dallas, TX, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 14, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010763707
- Address
- 3824 Cedar Springs Dr #422, Dallas, TX, United States, 75219
- Owner or operator
- Areza Medical (DBA for Advanced Medical Associates LLC) (10046301)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- August 17, 2022
- Registered through
- 2026
- Brand names listed
- Calcium Alginate Wound Dressing, Fabric Skin Tape (Fabripore), Foam Dressing, Foam Dressing with Adhesive Border, Island Wound Dressing (Bordered Gauze), One-Piece Open-Ended Drainable Colostomy & Ileostomy Bag with Velcro Closure & Carbon Filter, One-Piece Open-Ended Drainable Colostomy & Ileostomy Bag with Velcro Closure, Carbon Filter & Exhaust Valve, Sacral Ultra-Absorbent Silicone Foam Border and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Drainage, With Adhesive, Ostomy | FON | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 14, 2020 | K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| March 23, 2015 | K140954 | LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| February 14, 2013 | K120181 | LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Dressing, Wound, Drug
- All makers of Bag, Drainage, With Adhesive, Ostomy
- All makers of Dressing, Wound, Occlusive
Updated May 14, 2020. 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.