Arobella Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0534-2013Class IIArobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major cNovember 5, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K131096AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEMMay 16, 2014
K091038AS 1000 ULTRASOUND WOUND THERAPY SYSTEMJune 19, 2009
K062544AR1000 ULTRASONIC WOUND THERAPY SYSTEMJanuary 3, 2007