Data / Medical devices / United States / Biomed Laboratories LLC
Biomed Laboratories LLC: FDA-registered device maker in Dallas, TX, United States, 1 510(k) clearance
Biomed Laboratories LLC is registered with the FDA (registration 3006784948) in Dallas, TX, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 5, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006784948
- Address
- 8181 Eastpoint Drive, Dallas, TX, United States, 75227
- Owner or operator
- BIOMED LABORATORIES LLC (9103441)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 26, 2007
- Registered through
- 2026
- Brand names listed
- BIAKOS Antimicrobial Skin & Wound Cleanser, Rochal BIAKOS Antimicrobial Wound Gel, Vashe Wound Solution OTC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Stomal Appliance, Ostomy | EZR | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Contract manufacturer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Wound Dressings Containing Topical Analgesics | SEJ | U | Contract manufacturer | 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 5, 2011 | K100613 | BIOMED WOUND CLEANSER | FRO | Substantially Equivalent | Biomed Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 16, 2010 | 56564 | Not yet classified | Terminated | Reliamed Odor Eliminator Drops (8 oz, 4 oz, 1 oz package sizes) | The product may contain the mold Aspergillus ssp. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Wound Dressings Containing Topical Analgesics
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Cement, Stomal Appliance, Ostomy
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- All makers of Lubricant, Patient
Updated January 5, 2011. 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.