Data / Medical devices / United States / Recor Medical
Recor Medical: FDA-registered device maker in Palo Alto, CA, United States, 1 PMA approval
Recor Medical is registered with the FDA (registration 3010024164) in Palo Alto, CA, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated November 7, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010024164
- Address
- 1049 Elwell Ct, Palo Alto, CA, United States, 94303
- Owner or operator
- Recor Medical, Inc. (10082465)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 13, 2023
- Registered through
- 2027
- Brand names listed
- Paradise Cart, Paradise Ultrasound Renal Denervation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ablation Catheter, Renal Denervation | QYI | 3 | Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 7, 2023 | P220023 | Paradise® Ultrasound Renal Denervation System | QYI | 11 | August 13, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 29, 2026 | 98365 | Class II | Ongoing | Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | accessdata.fda.gov |
Compare with other makers
Updated August 13, 2026. 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.