Data / Medical devices / United States / Mac Medical
Mac Medical: FDA-registered device maker in Millstadt, IL, United States, 2 510(k) clearances
Mac Medical is registered with the FDA (registration 3006342679) in Millstadt, IL, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 5, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006342679
- Address
- 820 S. Mulberry ST, Millstadt, IL, United States, 62260
- Owner or operator
- MAC MEDICAL (9102921)
- Roles
- Contract manufacturer, Manufacturer, Remanufacturer
- First device listed
- June 13, 2007
- Registered through
- 2026
- Brand names listed
- MAC Medical D Series Warming Cabinet, MAC Medical IV Stand, STRETCHER, SWC/DWC Warming Cabinets, WHEELED, Warming Cabinets
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stand, Infusion | FOX | 1 | Contract manufacturer, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Stretcher, Wheeled | FPO | 2 | Contract manufacturer, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Warmer, Irrigation Solution | LHC | 1 | Contract manufacturer, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 5, 2019 | K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets | LGZ | Substantially Equivalent | Mac Medical, Inc. | accessdata.fda.gov |
| June 13, 2008 | K080609 | SWC/DWC WARMING CABINETS | LHC | Substantially Equivalent | Mac Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Stretcher, Wheeled
- All makers of Warmer, Thermal, Infusion Fluid
- All makers of Warmer, Irrigation Solution
- All makers of Stand, Infusion
Updated March 5, 2019. 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.