Abeon Medical Corporation
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
Catalogue
IntelAir Nasal Airway Support System Ref K142467
Regimes: 510(k) Registry: 510(k)Airway Support System / Airport Ref K131506
Regimes: 510(k) Registry: 510(k)
FDA recalls
2015
- 25 Nov 2015 Z-0684-2016 Class II Terminated The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Full distribution text
- 25 Nov 2015 Z-0685-2016 Class II Terminated The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Full distribution text
- 25 Nov 2015 Z-0686-2016 Class II Terminated The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Full distribution text
- 25 Nov 2015 Z-0684-2016 Class II Terminated The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Frequently asked questions
How many devices does Abeon Medical Corporation have in the registry?
The registry currently lists 2 devices for Abeon Medical Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abeon Medical Corporation's devices?
Among its 2 most recently registered devices, Abeon Medical Corporation has devices listed in FDA 510(k) (2 devices).
What risk classes do Abeon Medical Corporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Abeon Medical Corporation's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Abeon Medical Corporation?
FDA recall records list 3 recalls initiated by Abeon Medical Corporation, the most recent initiated on 25 Nov 2015. 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 Abeon Medical Corporation in the registry?
The most recently registered devices listed for Abeon Medical Corporation include IntelAir Nasal Airway Support System and AIRWAY SUPPORT SYSTEM / AIRPORT.