Data / Medical devices / United States / Innovate Medical, LLC
Innovate Medical, LLC: FDA-registered device maker in Johnson City, TN, United States, 1 510(k) clearance
Innovate Medical, LLC is registered with the FDA (registration 2321034) in Johnson City, TN, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2321034
- FEI number
- 3003399884
- Address
- 2210 Buffalo Road, Johnson City, TN, United States, 37604
- Owner or operator
- Innovate Medical, LLC (10028796)
- Roles
- Contract manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 6, 2009
- Registered through
- 2026
- Brand names listed
- INNOVATE MEDICAL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Covid-19 Test Home Collection Kit Devices | QLW | N | Repackager or relabeler | accessdata.fda.gov |
| Peripheral Blood Processing Device For Wound Management | PMQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Phlebotomy Blood Collection Kit | OFM | 2 | Contract manufacturer | accessdata.fda.gov |
| Protector, Hearing (Insert) | EWD | U | Repackager or relabeler | accessdata.fda.gov |
| Radiology-Diagnostic Kit | OIP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 12, 2003 | K032150 | SAFETY-MULTIFLY | FPA | Substantially Equivalent | Sarstedt, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Covid-19 Test Home Collection Kit Devices
- All makers of Tourniquet, Nonpneumatic
- All makers of Phlebotomy Blood Collection Kit
- All makers of Bandage, Elastic
- All makers of Set, Administration, Intravascular
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
Updated September 12, 2003. 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.