Canary Medical, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Canary Medical, Inc. makes
Canary Medical, Inc. manufactures the Tibial Extension, a device designed for orthopedic applications, paired with the Canary Health Implanted Reporting Processor (CHIRP) System for monitoring and data transmission. This system integrates with implanted components to provide real-time tracking and reporting of patient-specific metrics, primarily for lower limb orthopedic use.
The company’s portfolio is classified under FDA’s Class II regulatory category, requiring premarket notification (510(k)) clearance. The devices are listed in the FDA’s 510(k) database, adhering to U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System Ref DEN200064
Regimes: De Novo Registry: De Novo
FDA recalls
FDA recall records list 1 recall initiated by Canary Medical, Inc., initiated on 2025-05-02. By recorded status: 1 ongoing. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 2 May 2025 Z-2099-2025 Class II Ongoing Due to labeling error. Product incorrectly labeled.
Frequently asked questions
How many devices does Canary Medical, Inc. have in the registry?
The registry currently lists 1 device for Canary Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Canary Medical, Inc.'s devices?
Among its 1 most recently registered device, Canary Medical, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Canary Medical, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Canary Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Canary Medical, Inc.?
FDA recall records list 1 recall initiated by Canary Medical, Inc., the most recent initiated on 2 May 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Canary Medical, Inc. in the registry?
The most recently registered devices listed for Canary Medical, Inc. include Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System.