Edgewater Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Edgewater Medical Systems, Inc. makes
Edgewater Medical Systems, Inc. manufactures patient positioning accessories, including the Allen Prone Armboard and Allen Lateral Armboard, designed to support limbs during surgical procedures and medical imaging.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Allen Prone Armboard Ref K884838
Regimes: 510(k) Registry: 510(k)Allen Lateral Armboard Ref K881292
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Edgewater Medical Systems, Inc. have in the registry?
The registry currently lists 2 devices for Edgewater Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edgewater Medical Systems, Inc.'s devices?
Among its 2 most recently registered devices, Edgewater Medical Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Edgewater Medical Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Edgewater Medical Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Edgewater Medical Systems, Inc. in the registry?
The most recently registered devices listed for Edgewater Medical Systems, Inc. include ALLEN PRONE ARMBOARD and ALLEN LATERAL ARMBOARD.