Data / Medical devices / United States / SMD Manufacturing LLC
SMD Manufacturing LLC: FDA-registered device maker in Salt Lake City, UT, United States, 2 510(k) clearances
SMD Manufacturing LLC is registered with the FDA (registration 3013075752) in Salt Lake City, UT, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013075752
- Address
- 918 S 500 W Ste A, Salt Lake City, UT, United States, 84101
- Owner or operator
- SMD Manufacturing LLC (10052202)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 29, 2016
- Registered through
- 2026
- Brand names listed
- ReddyPort NIV Access Elbow, SMD, U-Tube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway Suction Kit | OFO | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dental Hygiene Kit | NXZ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Non-Life-Supporting | MNS | 2 | 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 |
|---|---|---|---|---|---|---|
| July 13, 2023 | K231064 | ReddyPort Elbow | MNS | Substantially Equivalent | Smd Manufacturing, LLC | accessdata.fda.gov |
| January 19, 2018 | K171827 | ReddyPort NIV Access Elbow | MNS | Substantially Equivalent | Smd Manufacturing, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Dental Hygiene Kit
- All makers of Ventilator, Continuous, Non-Life-Supporting
- All makers of Airway Suction Kit
- All makers of Mirror, Mouth
- All makers of Catheter And Tip, Suction
Updated July 13, 2023. 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.