Company · SE
Vitrolife Sweden AB
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2025. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2025 | K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCa Vitrolife Sweden AB, SE | MQF |
| Aug 30, 2024 | K241662 | Ultrasound Transducer Cover Vitrolife Sweden AB, SE | ITX |
| Aug 7, 2024 | K240605 | Ultra RapidWarm Blast Vitrolife Sweden AB, SE | MQL |
| May 14, 2021 | K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS Vitrolife Sweden AB, SE | MQL |
| Jul 26, 2019 | K183486 | RapidVit Oocyte, RapidWarm Oocyte Vitrolife Sweden AB, SE | MQL |
| Jan 4, 2019 | K181461 | Rapid-i Kit Vitrolife Sweden AB, SE | MQK |
| Nov 21, 2017 | K172050 | Follicle Aspiration Set, Reduced Single Lumen Vitrolife Sweden AB, SE | MQE |
| Jun 14, 2017 | K161970 | Follicle Aspiration Set Vitrolife Sweden AB, SE | MQE |
| Dec 21, 2015 | K150950 | FreezeKit Cleave , ThawKit Cleave Vitrolife Sweden AB | MQL |
| Dec 18, 2014 | K140207 | RAPID-I KIT Vitrolife Sweden AB | MQK |
| Oct 26, 2012 | K113786 | SPERMFREEZE SOLUTION Vitrolife Sweden AB, SE | MQL |
| Dec 10, 2010 | K101003 | RAPIDVIT BLAST, RAPIDWARM BLAST Vitrolife Sweden AB, SE | MQL |
| Dec 23, 2009 | K090832 | RAPID-I Vitrolife Sweden AB, SE | MQK |
| Feb 6, 2009 | K082727 | FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN Vitrolife Sweden AB, SE | MQE |
| Nov 26, 2008 | K080446 | RAPIDVIT AND RAPIDWARM CLEAVE Vitrolife Sweden AB, SE | MQL |
| Oct 9, 2008 | K081997 | PERFADEX WITH THAM Vitrolife Sweden AB, SE | MSB |
| Sep 17, 2008 | K081115 | G-MOPS G5 SERIES Vitrolife Sweden AB, SE | MQL |
| Sep 16, 2008 | K081117 | G-2 V5 Vitrolife Sweden AB, SE | MQL |
| Sep 16, 2008 | K081114 | G-1 V5 Vitrolife Sweden AB, SE | MQL |
| Sep 2, 2008 | K081116 | G-IVF G5 SERIES Vitrolife Sweden AB, SE | MQL |
| Jan 13, 2005 | K043116 | ICSI-100 Vitrolife Sweden AB, SE | MQL |
| May 7, 2004 | K033101 | G-PGD Vitrolife Sweden AB | MQL |
| May 7, 2004 | K032877 | G-OOCYTE Vitrolife Sweden AB | MQL |
| Jun 23, 2003 | K031015 | EMBRYOGLUE Vitrolife Sweden AB, SE | MQL |
| Dec 13, 2002 | K023403 | SPERMGRAD, MODELS 10022/10063 Vitrolife Sweden AB, SE | MQL |
| Sep 12, 2002 | K022295 | G-RINSE, MODEL 10031 Vitrolife Sweden AB, SE | MQL |
| Sep 6, 2002 | K022247 | G-SPERM, MODEL 10032 Vitrolife Sweden AB | MQL |
| Sep 6, 2002 | K022245 | G-FERT, MODEL 10033 Vitrolife Sweden AB | MQL |
| Sep 6, 2002 | K022244 | G-1 VERSION 3, MODEL 10048 Vitrolife Sweden AB | MQL |
| Sep 6, 2002 | K021896 | HSA-SOLUTION, MODEL 10034/10064 Vitrolife Sweden AB | MQL |
| Sep 6, 2002 | K021894 | G-MM, MODEL 10038 Vitrolife Sweden AB | MQL |
| Sep 6, 2002 | K021893 | G-MOPS, MODEL 10030 Vitrolife Sweden AB | MQL |
| Sep 6, 2002 | K021890 | G-2 VERSION 3, MODEL 10049 Vitrolife Sweden AB | MQL |
| Mar 8, 2001 | K000881 | PERFADEX SOLUTION FOR ORGAN PRESERVATION Vitrolife Sweden AB | MSB |
| May 17, 2000 | K991348 | IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 Vitrolife Sweden AB, SE | MQL |
| Feb 25, 2000 | K991351 | OVOIL-150, MODEL 5002 Vitrolife Sweden AB, SE | MQL |
| Feb 24, 2000 | K991346 | PH-100, MODEL 2104 Vitrolife Sweden AB, SE | MQL |
| Feb 18, 2000 | K991345 | ASP-100, MODEL 2100 Vitrolife Sweden AB, SE | MQL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||