Vitrolife AB
Medical device manufacturer in Bruckberg, DE.
5510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K192008 | LaserShot M, NaviLaseMRX · Abbreviated | 03/25/2020SE |
| K133568 | G-TlMQL · Traditional | 07/16/2014SE |
| K032155 | G-Thawkit BlastMQL · Traditional | 05/07/2004SE |
| K032154 | G-Freezekit BlastMQL · Traditional | 05/07/2004SE |
| K022730 | Perfadex Solution for Lung PreservationMSB · Traditional | 10/27/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1448-2015 Class II | SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml…The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation… | 12/22/2014Terminated |
| Z-2795-2011 | XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019…Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion… | 05/12/2011Terminated |