Data / Medical devices / United States / ABL Medical, LLC
ABL Medical, LLC: FDA-registered device maker in American Fork, UT, United States, 4 510(k) clearances
ABL Medical, LLC is registered with the FDA (registration 3007536356) in American Fork, UT, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated February 5, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007536356
- Address
- 705 E 50 S, American Fork, UT, United States, 84003
- Owner or operator
- ABL Medical, LLC (10029987)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 25, 2009
- Registered through
- 2026
- Brand names listed
- AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser, AGX Wound Wash Skin and Wound Cleanser, ASAP OTC Wound Dressing Gel, Armor Gel Wound Dressing Gel, CVS Wound Wash Antibacterial Silver Skin & Wound Cleanser, CareSTAT Wound Dressing Gel, ChemoBrain Shield Wound Dressing Gel, DJN Health Labs Super Silver Wound Dressing Gel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| February 5, 2016 | K151185 | AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) | FRO | Substantially Equivalent | Abl Medical, LLC | accessdata.fda.gov |
| May 20, 2014 | K140483 | ASAP OTC WOUND DRESSING GEL | FRO | Substantially Equivalent | Abl Medical, LLC | accessdata.fda.gov |
| November 12, 2009 | K092826 | ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL | FRO | Substantially Equivalent | American Biotech Labs | accessdata.fda.gov |
| April 2, 2009 | K082333 | ASAP WOUND DRESSING GEL | FRO | Substantially Equivalent | American Biotech Labs | accessdata.fda.gov |
Compare with other makers
Updated February 5, 2016. 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.