FDA product code NBF: Prosthesis, Retinal
NBF is the FDA product code for prosthesis, retinal. It is a HDE device, reviewed by the Ophthalmic panel. Devices under NBF reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Retinal |
| Device class | HDE |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for NBF devices
openFDA lists no recalls for product code NBF.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8608 — Miscellaneous external component, supply or accessory for use with the argus ii retinal prosthesis system
Frequently asked questions
What is FDA product code NBF?
NBF is the FDA product code for prosthesis, retinal. It is a HDE device, reviewed by the Ophthalmic panel.
What device class is NBF?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code NBF
- Run a recall and safety report across every NBF manufacturer
- Watch product code NBF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.