Edgewater Medical Equipment Systems
Country not established
- Devices
- 3
What Edgewater Medical Equipment Systems makes
Edgewater Medical Equipment Systems manufactures reusable anesthesia accessories, including malleable screens for surgical procedures and portable stirrups designed for patient positioning. Their product line also includes orderly trays, which are used to organize and transport medical supplies during surgical cases.
The company’s devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in operating rooms and surgical settings, adhering to U.S. medical device compliance standards.
Catalogue
Allen Malleable Anesthesia Screen Ref K873370
Regimes: 510(k) Registry: 510(k)The Portable Orderly Ref K872900
Regimes: 510(k) Registry: 510(k)Allen Universal Stirrup Ref K860177
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Edgewater Medical Equipment Systems have in the registry?
The registry currently lists 3 devices for Edgewater Medical Equipment Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edgewater Medical Equipment Systems's devices?
Among its 3 most recently registered devices, Edgewater Medical Equipment Systems has devices listed in FDA 510(k) (3 devices).
What risk classes do Edgewater Medical Equipment Systems's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Edgewater Medical Equipment Systems's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Edgewater Medical Equipment Systems in the registry?
The most recently registered devices listed for Edgewater Medical Equipment Systems include ALLEN MALLEABLE ANESTHESIA SCREEN, THE PORTABLE ORDERLY and ALLEN UNIVERSAL STIRRUP.