Data / Medical devices / United States / Zenith 11 Medical LLC
Zenith 11 Medical LLC: FDA-registered device maker in Key Largo, FL, United States, 2 510(k) clearances
Zenith 11 Medical LLC is registered with the FDA (registration 3031282706) in Key Largo, FL, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 21, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3031282706
- Address
- 99198 Overseas Hwy Ste 12, Key Largo, FL, United States, 33037
- Owner or operator
- Zenith 11 Medical LLC (10090757)
- Roles
- Repackager or relabeler
- First device listed
- September 19, 2025
- Registered through
- 2026
- Brand names listed
- ARM SUPPORT BOARD, INTRODUCER SHEATH KITS RADIAL, Push Click Y Connector Kit, Radial Artery Compression Tourniquets
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Board, Arm (With Cover), Non-Sterile | NOD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Introducer, Catheter | DYB | 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 |
|---|---|---|---|---|---|---|
| February 21, 2023 | K222184 | Introducer Sheath Kits | DYB | Substantially Equivalent | Beijing Demax Medical Technology Co.,Ltd | accessdata.fda.gov |
| January 4, 2023 | K222182 | Radial Artery Compression Tourniquets | DXC | Substantially Equivalent | Beijing Demax Medical Technology Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Board, Arm (With Cover), Non-Sterile
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Clamp, Vascular
Updated February 21, 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.