Vitrolife Sweden AB
Vastra Frolunda Vastra Gotaland, SE
VITROLIFE SWEDEN AB appears in FDA device records in Vastra Frolunda Vastra Gotaland, SE. FDA records list 38 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 38 510(k) clearances for Vitrolife Sweden AB between 2000 and 2025. The busiest year on record is 2002, with 9. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 4 |
| 2001 | 1 |
| 2002 | 9 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2008 | 6 |
| 2009 | 2 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2019 | 2 |
| 2021 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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) | MQF | Substantially Equivalent | |
| K241662 | Ultrasound Transducer Cover | ITX | Substantially Equivalent | |
| K240605 | Ultra RapidWarm™ Blast | MQL | Substantially Equivalent | |
| K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS | MQL | Substantially Equivalent | |
| K183486 | RapidVit™ Oocyte, RapidWarm™ Oocyte | MQL | Substantially Equivalent | |
| K181461 | Rapid-i™ Kit | MQK | Substantially Equivalent | |
| K172050 | Follicle Aspiration Set, Reduced Single Lumen | MQE | Substantially Equivalent | |
| K161970 | Follicle Aspiration Set | MQE | Substantially Equivalent | |
| K150950 | FreezeKit Cleave , ThawKit Cleave | MQL | Substantially Equivalent | |
| K140207 | RAPID-I KIT | MQK | Substantially Equivalent | |
| K113786 | SPERMFREEZE SOLUTION | MQL | Substantially Equivalent | |
| K101003 | RAPIDVIT BLAST, RAPIDWARM BLAST | MQL | Substantially Equivalent | |
| K090832 | RAPID-I | MQK | Substantially Equivalent | |
| K082727 | FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN | MQE | Substantially Equivalent | |
| K080446 | RAPIDVIT AND RAPIDWARM CLEAVE | MQL | Substantially Equivalent | |
| K081997 | PERFADEX WITH THAM | MSB | Substantially Equivalent | |
| K081115 | G-MOPS G5 SERIES | MQL | Substantially Equivalent | |
| K081117 | G-2 V5 | MQL | Substantially Equivalent | |
| K081114 | G-1 V5 | MQL | Substantially Equivalent | |
| K081116 | G-IVF G5 SERIES | MQL | Substantially Equivalent | |
| K043116 | ICSI-100 | MQL | Substantially Equivalent | |
| K033101 | G-PGD | MQL | Substantially Equivalent | |
| K032877 | G-OOCYTE | MQL | Substantially Equivalent | |
| K031015 | EMBRYOGLUE | MQL | Substantially Equivalent | |
| K023403 | SPERMGRAD, MODELS 10022/10063 | MQL | Substantially Equivalent | |
| K022295 | G-RINSE, MODEL 10031 | MQL | Substantially Equivalent | |
| K022247 | G-SPERM, MODEL 10032 | MQL | Substantially Equivalent | |
| K022245 | G-FERT, MODEL 10033 | MQL | Substantially Equivalent | |
| K022244 | G-1 VERSION 3, MODEL 10048 | MQL | Substantially Equivalent | |
| K021896 | HSA-SOLUTION, MODEL 10034/10064 | MQL | Substantially Equivalent | |
| K021894 | G-MM, MODEL 10038 | MQL | Substantially Equivalent | |
| K021893 | G-MOPS, MODEL 10030 | MQL | Substantially Equivalent | |
| K021890 | G-2 VERSION 3, MODEL 10049 | MQL | Substantially Equivalent | |
| K000881 | PERFADEX SOLUTION FOR ORGAN PRESERVATION | MSB | Substantially Equivalent | |
| K991348 | IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 | MQL | Substantially Equivalent | |
| K991351 | OVOIL-150, MODEL 5002 | MQL | Substantially Equivalent | |
| K991346 | PH-100, MODEL 2104 | MQL | Substantially Equivalent | |
| K991345 | ASP-100, MODEL 2100 | MQL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003995932 | 3003995932 | VITROLIFE SWEDEN AB | Gustaf Werners Gata 2, Vastra Frolunda Vastra Gotaland SE-421 32 SE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MQFCatheter, Assisted Reproduction
- MQKLabware, Assisted Reproduction
- PUDLabware, Assisted Reproduction, Exempt
- MQLMedia, Reproductive
- QKIMedia, Reproductive, Exempt
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt
- MQENeedle, Assisted Reproduction
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- MSBSystem And Accessories, Isolated Heart, Transport And Preservation
- ITXTransducer, Ultrasonic, Diagnostic
- GAZTubing, Noninvasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain