Delaware Prosthetics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Delaware Prosthetics, Inc. makes
Delaware Prosthetics, Inc. manufactures silicone-based prosthetic devices for facial reconstruction, including ears, noses, obturators for cleft palate, orbital implants, and chin implants. These products are designed to restore form and function for patients with congenital or acquired facial deficiencies.
The company’s portfolio includes Class I and Class II devices, with products authorised via the FDA’s 510(k) pathway. These prosthetics are listed under U.S. regulatory requirements and are intended for use in medical settings.
Catalogue
Pdm Siloxane Prosthetic Ear Ref K832152
Regimes: 510(k) Registry: 510(k)Pdm Siloxane Prosthetic Nose Ref K832153
Regimes: 510(k) Registry: 510(k)Pdm Siloxane Prosthetic Obturator Ref K832149
Regimes: 510(k) Registry: 510(k)Pdm Siloxane Prosthetic Orbit Ref K832151
Regimes: 510(k) Registry: 510(k)Pdm Siloxane Prosthetic Chin Implant Ref K832148
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Delaware Prosthetics, Inc. have in the registry?
The registry currently lists 5 devices for Delaware Prosthetics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Delaware Prosthetics, Inc.'s devices?
Among its 5 most recently registered devices, Delaware Prosthetics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Delaware Prosthetics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Delaware Prosthetics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Delaware Prosthetics, Inc. in the registry?
The most recently registered devices listed for Delaware Prosthetics, Inc. include PDM SILOXANE PROSTHETIC EAR, PDM SILOXANE PROSTHETIC NOSE, PDM SILOXANE PROSTHETIC OBTURATOR and PDM SILOXANE PROSTHETIC ORBIT.