10 results
·
51ms
·
Sources: EU EUDAMED, US FDA
REGENESIS BIOMEDICAL, INC.
FDA registration
REGENESIS BIOMEDICAL, INC.·2 products·🇺🇸 United States
Reprieve by Regenesis
FDA UDI
Regenesis Biomedical, Inc.·00868924000038·The Reprieve by Regenesis device is a home-use ...
Disposable Applicator Cover
FDA UDI
Regenesis Biomedical, Inc.·20868924000018·Disposable Applicator Covers are single-use-onl...
Provant Infinity
FDA UDI
Regenesis Biomedical, Inc.·00868924000021·The device includes a Control Unit and Treatmen...
Provant Therapy System
FDA UDI
Regenesis Biomedical, Inc.·00868924000007·The device includes a Control Unit and Treatmen...
PROVANT WOUND THERAPY SYSTEM
FDA Adverse Event
Injury
·REGENESIS BIOMEDICAL, INC.·Product code ILX·March 23, 2009
PROVANT THERAPY SYSTEM
FDA Adverse Event
Injury
·REGENESIS BIOMEDICAL, INC.·Product code ILX·July 13, 2011
PROVANT WOUND THERAPY SYSTEM
FDA Adverse Event
Injury
·REGENESIS BIOMEDICAL, INC.·Product code ILX·June 5, 2008
PROVANT WOUND THERAPY SYSTEM
FDA Adverse Event
Injury
·REGENESIS BIOMEDICAL, INC.·Product code ILX·September 18, 2008
Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
FDA Recall
Terminated
·Regenesis Biomedical Inc·Product code ILX·September 29, 2008