FDA 510(k) Applications for Medical Device Product Code "NRB"
(Wound Cleaner, Ultrasound)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K162721 |
ALLIQUA BIOMEDICAL, INC. |
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator |
12/22/2016 |
K131096 |
AROBELLA MEDICAL, LLC |
AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM |
05/16/2014 |
K091038 |
AROBELLA MEDICAL, LLC |
AS 1000 ULTRASOUND WOUND THERAPY SYSTEM |
06/19/2009 |
DEN040004 |
CELLERATION |
CELLERATION MIST THERAPY SYSTEM |
06/25/2004 |
K050129 |
CELLERATION, INC. |
CELLERATION MIST THERAPY SYSTEM 5.1 |
05/17/2005 |
K122246 |
CELLERATION, INC. |
MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 |
08/13/2012 |
K140782 |
CELLERATION, INC. |
ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR |
08/13/2014 |
K112782 |
MISONIX, INC. |
MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES |
12/01/2011 |
K123980 |
MISONIX, INC. |
SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES |
03/05/2013 |
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