Company ยท US
Vitrolife AB
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2020. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 25, 2020 | K192008 | LaserShot M, NaviLase Vitrolife GmbH, DE | MRX |
| Jul 16, 2014 | K133568 | G-TL Vitrolife, Inc. | MQL |
| May 7, 2004 | K032155 | G-THAWKIT BLAST Vitrolife AB | MQL |
| May 7, 2004 | K032154 | G-FREEZEKIT BLAST Vitrolife AB | MQL |
| Oct 27, 2003 | K022730 | PERFADEX SOLUTION FOR LUNG PRESERVATION Vitrolife AB | MSB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2015 | Vitrolife Inc SpermMar Test
0.7ml Beads Particles
Label on bottle:
SpermMar Test IgA
0.7ml Beads/Particles-50 Tests
IND REF SPMA_S
LOT Expiration
DO NOT FREEZE/NE PAS CONGELER
FertiPro N.V.
Label on box:
SpermM Terminated |
KTO | None listed |
| Jul 12, 2011 | Vitrolife, Inc. XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs.
Perfadex with THAM kits, Terminated |
MSB | K081997 |