Wfr/aquaplast Corp

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1264-2016Class IIClear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage:January 7, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K120916QFIX RADIOTHERAPY CHAIRJune 20, 2012
K060671KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUSMay 4, 2006
K032156ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION,September 2, 2003
K021124ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDERJuly 2, 2002
K973370AQUAPLAST PALATAL STENTDecember 2, 1997
K943871AQUAPLAST TIE DOWN DRESSINGSeptember 30, 1994
K942158AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITSJuly 29, 1994
K935067AQUAPLASTMay 26, 1994