Motiva USA, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Motiva USA, LLC makes
Motiva USA, LLC manufactures breast tissue expanders, including the Motiva Flora SmoothSilk Tissue Expander, and single-use, sterile silicone breast sizers for intraoperative assessment. Their portfolio also includes silicone gel-filled breast implants, such as the Motiva SmoothSilk Round Ergonomix and Motiva SmoothSilk Round Silicone Gel-Filled Breast Implants.
These devices are classified under Class III and Class U regulatory categories in the US. They are authorised via FDA pathways, including 510(k) clearances and Premarket Approval (PMA) applications. The company is based in the United States.
Catalogue
Motiva Flora SmoothSilk Tissue Expander Ref K211676
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Motiva USA, LLC have in the registry?
The registry currently lists 3 devices for Motiva USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Motiva USA, LLC's devices?
Among its 3 most recently registered devices, Motiva USA, LLC has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Motiva USA, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Motiva USA, LLC's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Motiva USA, LLC in the registry?
The most recently registered devices listed for Motiva USA, LLC include Motiva Flora SmoothSilk Tissue Expander, Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix and Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas.