Tissium SA
FranceFDA applicant, unverified FDA FEI 3021453307
Tissium SA is a medical device manufacturer, with 20 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 8 FDA recalls as of 13 Nov 2026.
- Devices
- 20
- Registrations
- FDA
- FDA recalls
- 88 ongoing
Registry facts
- Registries
- FDA GUDID 18
- FDA 510(k) 2
- Device classes
- FDA Class II 19
- FDA Class I 1
- FDA recalls
- Identifiers
- FDA FEI 3021453307
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 20 devicesCompany details
- FDA FEI number
- 3021453307
- Address
- 18 Avenue Leon Gaumont, Paris 20e Arrondissement
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 8
2026
- 15 Jun 2026 Z-2901-2026 Class II Ongoing Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
- 15 Jun 2026 Z-2902-2026 Class II Ongoing Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
- 15 Jun 2026 Z-2903-2026 Class II Ongoing Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
- 15 Jun 2026 Z-2904-2026 Class II Ongoing Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
- 15 Jun 2026 Z-2905-2026 Class II Ongoing Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
- 15 Jun 2026 Z-2906-2026 Class II Ongoing Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
- 15 Jun 2026 Z-2907-2026 Class II Ongoing Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
- 15 Jun 2026 Z-2908-2026 Class II Ongoing Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Frequently asked questions
How many devices does Tissium SA have in the registry?
The registry currently lists 20 devices for Tissium SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tissium SA's devices?
Among its 20 most recently registered devices, Tissium SA has devices listed in FDA 510(k) (2 devices) and FDA GUDID (18 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Tissium SA's devices fall under?
Among its 20 most recently registered devices, the classes recorded for Tissium SA's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Tissium SA?
FDA recall records list 8 recalls initiated by Tissium SA, the most recent initiated on 15 Jun 2026. 8 of them are 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 Tissium SA in the registry?
The most recently registered devices listed for Tissium SA include COAPTIUM® Selector NCOSE0001, COAPTIUM® Connect NCOCO4015, COAPTIUM® Connect NCOCO4010 and COAPTIUM® Connect NCOCO5010.