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United States·US-MF-000027816
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1049, Elwell Court, Palo Alto, United States
- Website
- www.recormedical.com
- —
- —
- [email protected]
- Phone
- +16505427700
- PRRC Contact
- Thomas Ting
- EUDAMED SRN
- US-MF-000027816
- FDA FEI Number
- 3010024164
- DUNS Number
- 943549670
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Paradise® Cart | PRDS-CRT | FDA UDI | Class I | Active |
| Paradise® Catheter | PRDS-065-02 | FDA UDI | Class III | Active |
| Paradise® Connection Cable | PRDS-CC-02 | FDA UDI | Class III | Active |
| Paradise® Cartridge | PRDS-CT-02 | FDA UDI | Class III | Active |
| Paradise® Remote | PRDS-RM | FDA UDI | Class III | Active |
| Paradise® Ultrasound Renal Denervation System | P220023 | FDA PMA | Class III | Active |
| Paradise™ | PRDS-USG-2X | EUDAMEDFDA UDI | Class IIb | Active |
Related Companies
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Importers
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Authorities
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FDA Recalls (2)
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 |
|---|---|---|---|---|
| Jan 29, 2026 | Z-1655-2026 | — | open, classified | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. |
| Jan 29, 2026 | Z-1654-2026 | — | open, classified | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. |