Vitrolife Sweden AB

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
38
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (July 23, 2025
K241662Ultrasound Transducer CoverAugust 30, 2024
K240605Ultra RapidWarm™ BlastAugust 7, 2024
K202862Gx-IVF, Gx-TL, Gx-MOPS PLUSMay 14, 2021
K183486RapidVit™ Oocyte, RapidWarm™ OocyteJuly 26, 2019
K181461Rapid-i™ KitJanuary 4, 2019
K172050Follicle Aspiration Set, Reduced Single LumenNovember 21, 2017
K161970Follicle Aspiration SetJune 14, 2017
K150950FreezeKit Cleave , ThawKit CleaveDecember 21, 2015
K140207RAPID-I KITDecember 18, 2014
K113786SPERMFREEZE SOLUTIONOctober 26, 2012
K101003RAPIDVIT BLAST, RAPIDWARM BLASTDecember 10, 2010
K090832RAPID-IDecember 23, 2009
K082727FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMENFebruary 6, 2009
K080446RAPIDVIT AND RAPIDWARM CLEAVENovember 26, 2008
K081997PERFADEX WITH THAMOctober 9, 2008
K081115G-MOPS G5 SERIESSeptember 17, 2008
K081117G-2 V5September 16, 2008
K081114G-1 V5September 16, 2008
K081116G-IVF G5 SERIESSeptember 2, 2008