Panels › General, Plastic Surgery › Product code NRB · Class 2
Wound Cleaner, Ultrasound
Regulation 878.4410
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NRB
| Company | 510(k)s | Recalls |
|---|---|---|
| Celleration | 4 | 0 |
| Arobella Medical, LLC | 2 | 0 |
| Misonix, Inc. | 2 | 0 |
| Alliqua Biomedical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2016 | K162721 | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator Alliqua Biomedical, Inc. | NRB |
| Aug 13, 2014 | K140782 | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR Celleration, Inc. | NRB |
| May 16, 2014 | K131096 | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM Arobella Medical, LLC | NRB |
| Mar 5, 2013 | K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES Misonix, Inc. | NRB |
| Aug 13, 2012 | K122246 | MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 Celleration, Inc. | NRB |
| Dec 1, 2011 | K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES Misonix, Inc. | NRB |
| Jun 19, 2009 | K091038 | AS 1000 ULTRASOUND WOUND THERAPY SYSTEM Arobella Medical, LLC | NRB |
| May 17, 2005 | K050129 | CELLERATION MIST THERAPY SYSTEM 5.1 Celleration, Inc. | NRB |
| Jun 25, 2004 | DEN040004 | CELLERATION MIST THERAPY SYSTEM Celleration | NRB |
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