Orbit Biomedical
Country not established
- Devices
- 2
What Orbit Biomedical makes
Orbit Biomedical manufactures the Orbit Subretinal Delivery System, a device designed for targeted delivery of therapeutic agents to the subretinal space in ocular treatments.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. The devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Orbit Subretinal Delivery System Ref K182274
Regimes: 510(k) Registry: 510(k)Orbit Subretinal Delivery System Ref K200325
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orbit Biomedical have in the registry?
The registry currently lists 2 devices for Orbit Biomedical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orbit Biomedical's devices?
Among its 2 most recently registered devices, Orbit Biomedical has devices listed in FDA 510(k) (2 devices).
What risk classes do Orbit Biomedical's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Orbit Biomedical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orbit Biomedical in the registry?
The most recently registered devices listed for Orbit Biomedical include Orbit Subretinal Delivery System.