Valeris Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
Catalogue
BoneCam Suture Anchors Ref K152255
Regimes: 510(k) Registry: 510(k)Apollo Suture Anchor System Ref K192810
Regimes: 510(k) Registry: 510(k)Apollo Suture Anchor System and Titan Screws Ref K142230
Regimes: 510(k) Registry: 510(k)Bonecam Suture Anchor Ref K193108
Regimes: 510(k) Registry: 510(k)
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 2
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 16 Jul 2018 Z-0104-2019 Class II Terminated The product was mislabeled as containing the incorrect type of suture.
- 22 Jan 2018 Z-2430-2018 Class II Terminated The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the anchor screw material was titanium, however that part number is made of PEEK.
Frequently asked questions
How many devices does Valeris Medical, Inc. have in the registry?
The registry currently lists 4 devices for Valeris Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Valeris Medical, Inc.'s devices?
Among its 4 most recently registered devices, Valeris Medical, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Valeris Medical, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Valeris Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Valeris Medical, Inc.?
FDA recall records list 2 recalls initiated by Valeris Medical, Inc., the most recent initiated on 16 Jul 2018. 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 Valeris Medical, Inc. in the registry?
The most recently registered devices listed for Valeris Medical, Inc. include BoneCam Suture Anchors, Apollo Suture Anchor System, Apollo Suture Anchor System and Titan Screws and Bonecam Suture Anchor.