Swissray Medical

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
4
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0697-2019Class IIddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRNovember 14, 2018
Z-3191-2018Class IIddR Formula B X-ray System, Model ddR Formula B X-ray system used for imagingNovember 18, 2016
Z-3248-2018Class IIddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imagingAugust 9, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K131314DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)June 25, 2013
K123005DDRVERSA MOTIONDecember 7, 2012
K110828DDRELEMENTAugust 23, 2011
K052943DDRFORMULA AND DDRFORMULA PLUSDecember 15, 2005