Mimedx Group, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Mimedx Group, Inc. makes
Mimedx Group, Inc. manufactures sterile surgical drapes and protective barriers, including the HydroFix Vaso Shield and HydroFix Surgical Sheet, designed for use in vascular and general surgical procedures to maintain sterile fields and reduce contamination risk.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Hydrofix Vaso Shield Ref K111137
Regimes: 510(k) Registry: 510(k)Hydrofix Vaso Shield, Model Hvs-001-0610 Ref K101826
Regimes: 510(k) Registry: 510(k)Hydrofix Vaso Shield Ref K101805
Regimes: 510(k) Registry: 510(k)Hydrofix Surgical Sheet Ref K100905
Regimes: 510(k) Registry: 510(k)Hydrofix Surgical Sheet Ref K100313
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mimedx Group, Inc. have in the registry?
The registry currently lists 5 devices for Mimedx Group, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mimedx Group, Inc.'s devices?
Among its 5 most recently registered devices, Mimedx Group, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Mimedx Group, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Mimedx Group, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mimedx Group, Inc. in the registry?
The most recently registered devices listed for Mimedx Group, Inc. include HYDROFIX VASO SHIELD, HYDROFIX VASO SHIELD, MODEL HVS-001-0610 and HYDROFIX SURGICAL SHEET.