Vitrolife Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
9
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1448-2015Class IISpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-5December 22, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K213869EmbryoSlide+ ic8 dishMarch 11, 2022
K192008LaserShot M, NaviLaseMarch 25, 2020
K182798KIDScore D3July 19, 2019
K173264EmbryoScope+May 11, 2018
K150961EmbryoSlide Culture DishDecember 4, 2015
K133568G-TLJuly 16, 2014
K032154G-FREEZEKIT BLASTMay 7, 2004
K032155G-THAWKIT BLASTMay 7, 2004
K022730PERFADEX SOLUTION FOR LUNG PRESERVATIONOctober 27, 2003