Is this your brand? Sign in to claim ownership.
Sign in to claim this brandMicrotek Medical LLC
United States·US-MF-000019222
Last updated September 17, 2026
Information
- Country
- United States
- Address
- Three, Lakes Drive, Northfield, United States
- Website
- www.microtekmed.com
- —
- —
- [email protected]
- Phone
- 1-800-Medline
- PRRC Contact
- Lam Duong
- EUDAMED SRN
- US-MF-000019222
- FDA FEI Number
- 3014342658
- DUNS Number
- 106908437
Catalogue (1418)
Page 28 of 29| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Microtek | 1 | FDA UDI | Class II | Active |
| Ecolab | Hush Slush Equipment | FDA UDI | Class I | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Medline-Microtek | Drainage Bags | FDA UDI | Class I | Active |
| Medline-Microtek | Equipment Drapes | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Medline-Microtek | Surgical Slush - Hush-Slush Drape | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Velys™ | Equipment Drapes | FDA UDI | Class II | Active |
| Medline-Microtek | Patient Drapes | FDA UDI | Class II | Active |
| Medline-Microtek | Fluid Warming - Warmer Equipment | FDA UDI | Class I | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Medline-Microtek | Drainage Bags | FDA UDI | Class I | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Armatec® | Equipment Drapes | FDA UDI | Class II | Active |
| Medtronic | Equipment Drapes | FDA UDI | Class II | Active |
| Armatec® | Equipment Drapes | FDA UDI | Class II | Active |
| Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | K251676 | FDA 510(k) | Class II | Active |
| Microtek Intranasal Splint | K862496 | FDA 510(k) | Class I | Active |
| Venodyne Dvt Advantage Model 610 | K001802 | FDA 510(k) | Class II | Active |
| Gold Alligator Forceps | K833608 | FDA 510(k) | Class I | Active |
| Lesinski Surgical Ear Dressing | K950906 | FDA 510(k) | U | Active |
| Venodyne Dvt Advantage Plus | K011318 | FDA 510(k) | Class II | Active |
| Antrum & Attic Mirror | K833601 | FDA 510(k) | Class I | Active |
| Venodyne V810 | K110358 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (25)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 13, 2025 | Z-1963-2025 | — | open, classified | Due to non-sterile products being labeled as sterile |
| Jun 3, 2024 | Z-2643-2024 | — | open, classified | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. |
| Jun 3, 2024 | Z-2639-2024 | — | open, classified | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. |
| Jun 3, 2024 | Z-2640-2024 | — | open, classified | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. |
| Jun 3, 2024 | Z-2642-2024 | — | open, classified | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. |
| Jun 3, 2024 | Z-2641-2024 | — | open, classified | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. |
| Jun 23, 2023 | Z-2251-2023 | — | open, classified | Certain lots of the products have a Naphthalene odor. |
| Jun 23, 2023 | Z-2250-2023 | — | open, classified | Certain lots of the products have a Naphthalene odor. |
| Apr 8, 2022 | Z-1071-2022 | — | terminated | Latex content in product was labeled incorrectly as latex free. |
| Mar 10, 2015 | Z-1348-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1342-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1349-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1344-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1337-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1346-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1341-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1339-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1347-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1343-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1340-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1338-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1345-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Jan 5, 2011 | Z-1885-2011 | — | terminated | Product contains Triad Lubricating Jelly which was recalled. |
| Aug 23, 2010 | Z-0592-2011 | — | terminated | This product is being recalled due the product is miss-labeled as being sterilized by EO processing; however, the product was processed using Gamma sterilization. |
| May 25, 2010 | Z-2109-2010 | — | terminated | Product labeled as sterile was distributed without sterilization. |