Elutia Inc.
Country not established FDA establishment FEI 3031160994
- Devices
- 8
- Registrations
- FDA
- FDA recalls
- 0
Catalogue
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
CanGaroo RM Antibacterial Envelope Ref K233991
510(k) 510(k)
Company details
- FDA FEI number
- 3031160994
- Address
- 20 Firstfield Rd, Gaithersburg, MD, 20878
Frequently asked questions
How many devices does ELUTIA INC. have in the registry?
The registry currently lists 8 devices for ELUTIA INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ELUTIA INC.'s devices?
Among its 8 most recently registered devices, ELUTIA INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ELUTIA INC.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for ELUTIA INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from ELUTIA INC. in the registry?
The most recently registered devices listed for ELUTIA INC. include ProxiCor for Pericardial Closure CMCV-059-401, VasCure for Vascular Repair CMCV-013-609, VasCure for Vascular Repair CMCV-011-606 and ProxiCor for Pericardial Closure CMCV-060-402.