Data / Medical devices / United States / Microtek Medical LLC
Microtek Medical LLC: FDA-registered device maker in Eagan, MN, United States, 6 510(k) clearances
Microtek Medical LLC is registered with the FDA (registration 3021970868) in Eagan, MN, United States. It lists 18 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 6, 2005. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021970868
- Address
- 990 Lone Oak Road Suite 130, Eagan, MN, United States, 55121
- Owner or operator
- Medline Industries, LP (1417592)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 30, 1991
- Registered through
- 2027
- Brand names listed
- "Salt Airway S.A.L.T.", ACCU-SORB, AKTORmed, Accu-Wrap, Aquablation Therapy, BEDDING, BERMAN AIRWAYS, Bandages and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| June 6, 2005 | K050776 | AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | Misonix, Inc. | accessdata.fda.gov |
| December 2, 1991 | K914077 | REPEL(TM) LITE CUT RESISTANT GLOVE LINERS | LYU | Substantially Equivalent | Depuy-Raynham | accessdata.fda.gov |
| June 18, 1981 | K811268 | BOTTLE-TO-BOTTLE | KPE | Substantially Equivalent | Medi-Plast Intl., Inc. | accessdata.fda.gov |
| June 18, 1981 | K811234 | I.V. BOTTLE (RIDGID) | KPE | Substantially Equivalent | Medi-Plast Intl., Inc. | accessdata.fda.gov |
| June 17, 1981 | K811233 | I.V. PLASTIC BAG | KPE | Substantially Equivalent | Medi-Plast Intl., Inc. | accessdata.fda.gov |
| June 16, 1981 | K811269 | GLASS VIALS | KPE | Substantially Equivalent | Medi-Plast Intl., Inc. | accessdata.fda.gov |
Compare with other makers
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Updated June 6, 2005. 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.