Odam
Country not established
- Devices
- 6
What Odam makes
Odam manufactures implantable and external defibrillator devices, including the MINIDEF (or DEFIPORT), DEFIGARD 2000, and MAGLIFE series, which are designed for cardiac rhythm management. Their portfolio also includes the CARIEL F12, an external defibrillator, and the DEFIGARD M (or DEFISCOPE M), a portable monitoring and defibrillation device.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. Odam’s products are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Minidef (Or Defiport Ref K823933
Regimes: 510(k) Registry: 510(k)Defigard 2000 Ref K854175
Regimes: 510(k) Registry: 510(k)Maglife C Ref K972535
Regimes: 510(k) Registry: 510(k)Defigard M(Or Defiscope M Ref K823931
Regimes: 510(k) Registry: 510(k)Maglife Ref K950264
Regimes: 510(k) Registry: 510(k)Cariel F12 Ref K823934
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Odam have in the registry?
The registry currently lists 6 devices for Odam. Devices recorded under merged duplicate company entries are counted once.
Which registries list Odam's devices?
Among its 6 most recently registered devices, Odam has devices listed in FDA 510(k) (6 devices).
What risk classes do Odam's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Odam's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Odam in the registry?
The most recently registered devices listed for Odam include MINIDEF (OR DEFIPORT, DEFIGARD 2000, MAGLIFE C and DEFIGARD M(OR DEFISCOPE M.