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Vitrolife Sweden AB

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories5
Latest FDA decision2025-07-23
TypeNumberDevice NameCodeDateActions
510(k) K243373 Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)MQF2025-07-23 View
510(k) K241662 Ultrasound Transducer CoverITX2024-08-30 View
510(k) K240605 Ultra RapidWarm™ BlastMQL2024-08-07 View
510(k) K202862 Gx-IVF, Gx-TL, Gx-MOPS PLUSMQL2021-05-14 View
510(k) K183486 RapidVit™ Oocyte, RapidWarm™ OocyteMQL2019-07-26 View
510(k) K181461 Rapid-i™ KitMQK2019-01-04 View
510(k) K172050 Follicle Aspiration Set, Reduced Single LumenMQE2017-11-21 View
510(k) K161970 Follicle Aspiration SetMQE2017-06-14 View
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