Data / Medical devices / United States / Canary Medical Usa LLC
Canary Medical Usa LLC: FDA-registered device maker in Carlsbad, CA, United States, 2 510(k) clearances
Canary Medical Usa LLC is registered with the FDA (registration 3015802419) in Carlsbad, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 24, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015802419
- Address
- 2710 Loker Ave. West, Suite 350, Carlsbad, CA, United States, 92010
- Owner or operator
- Canary Medical, Inc. (10082445)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 28, 2021
- Registered through
- 2026
- Brand names listed
- CanarE, CanarE Charger, CanarE Clinic Cart, CanarE Straps, Canary Clinic Laptop, Canary Clinical Base Station, Canary Cloud Data Management Platform, Canary Medical Gait Parameters and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Goniometer, Ac-Powered | KQX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Goniometer, Nonpowered | KQW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Implantable Post-Surgical Kinematic Measurement Knee Device | QPP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 24, 2024 | K234056 | canturio® se (Canturio Smart Extension) | QPP | Substantially Equivalent | Canary Medical USA, LLC | accessdata.fda.gov |
| August 27, 2021 | DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System | QPP | Unknown | Canary Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 2, 2025 | 96894 | Class II | Ongoing | Brand Name: Canturio Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona Personalized Knee System; 14mm diameter x 30mm he | Due to labeling error. Product incorrectly labeled. | accessdata.fda.gov |
Compare with other makers
- All makers of Implantable Post-Surgical Kinematic Measurement Knee Device
- All makers of Medical Device Data System
- All makers of Goniometer, Ac-Powered
- All makers of Goniometer, Nonpowered
Updated July 8, 2025. 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.