American Custom Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Tefgen Guided Tissue Membrane Ref K964656
Regimes: 510(k) Registry: 510(k)Tefgen-Fd Ref K935137
Regimes: 510(k) Registry: 510(k)Tefgen - Ls Ref K965205
Regimes: 510(k) Registry: 510(k)Acm Ptfe Surgical Mesh Ref K944413
Regimes: 510(k) Registry: 510(k)Fluorofilm(R) Ref K933800
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Custom Medical, Inc. have in the registry?
The registry currently lists 5 devices for American Custom Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Custom Medical, Inc.'s devices?
Among its 5 most recently registered devices, American Custom Medical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do American Custom Medical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for American Custom Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Custom Medical, Inc. in the registry?
The most recently registered devices listed for American Custom Medical, Inc. include TEFGEN GUIDED TISSUE MEMBRANE, TEFGEN-FD, TEFGEN - LS and ACM PTFE SURGICAL MESH.