Media, Reproductive
FDA product code MQL · Class II (moderate risk) · 21 CFR 884.6180 · Obstetrics/Gynecology
260510(k) clearances
0PMA approvals
15recalls
Manufacturers
- Irvine Scientific Sales Co., Inc. 36
- Vitrolife Sweden AB 28
- Medicult A/S 26
- <Genx> Intl., Inc. 20
- Nidacon International AB 11
- William A. Cook Australia Pty. , Ltd. 10
- Origio A/S 10
- Invitrocare, Inc. 10
- Kitazato Corporation 8
- Vitrolife AB/Scandinavian Ivf Sciences AB 7
- Conception Technologies 7
- Sage Biopharma 6
- Vitromed GmbH 6
- Advanced Reproductive Technologies 5
- Cook Urological, Inc. 5
- Gimbo Medical Technology Shenzhen Co., Ltd. 5
- Hamilton Thorne, Inc. 4
- Cook Ob/Gyn 4
- Donnevie Medical Technology (Shanghai) Co. , Ltd. 4
- Kitazato Biopharma Co., Ltd. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)MQL · Traditional | Cell Store (Beijing) Biotechnology Co., Ltd. | 08/28/2026SE |
| K260248 | Ultra-Fast WarmMQL · Traditional | Kitazato Corporation | 04/28/2026SE |
| K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)MQL · Traditional | Casebioscience, Inc. | 02/20/2026SE |
| K250445 | Fast Warm - NXMQL · Traditional | Fujifilm Irvine Scientific | 09/12/2025SE |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 08/27/2025SE |
| K251305 | Ultra-Fast Vitri; Ultra-Fast WarmMQL · Traditional | Kitazato Corporation | 08/26/2025SE |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinMQL · Traditional | Fertipro NV | 05/30/2025SE |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 04/10/2025SE |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)MQL · Traditional | Jiangsu Ruifuda Medical Device Co., Ltd. | 04/10/2025SE |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC)…MQL · Traditional | Casebioscience, Inc. | 03/21/2025SE |
| K241833 | V-GradMQL · Traditional | Vitromed GmbH | 03/21/2025SE |
| K242043 | Sperm Freezing MediumMQL · Traditional | Gimbo Medical Technology Shenzhen Co., Ltd. | 01/08/2025SE |
| K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)MQL · Traditional | Artsmedia Denmark Aps | 12/18/2024SE |
| K241095 | ARTSMedia Semen Wash MediumMQL · Traditional | Artsmedia Denmark Aps | 12/18/2024SE |
| K242968 | Giftlife® Single-Step Medium PlusMQL · Traditional | Gimbo Medical Technology Shenzhen Co., Ltd. | 11/22/2024SE |
| K240176 | V-VITFREEZE and V-VITWARMMQL · Traditional | Vitromed GmbH | 09/13/2024SE |
| K233846 | Vitrification Solution Set and Warming Solution SetMQL · Traditional | Ecmpc, LLC | 08/27/2024SE |
| K240605 | Ultra RapidWarm BlastMQL · Traditional | Vitrolife Sweden AB | 08/07/2024SE |
| K233477 | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML…MQL · Traditional | Shandong Wego Ruisheng Medical Device Co., Ltd. | 07/01/2024SE |
| K240149 | Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium…MQL · Traditional | Gimbo Medical Technology Shenzhen Co., Ltd. | 06/13/2024SE |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete BufferMQL · Traditional | Gimbo Medical Technology Shenzhen Co., Ltd. | 05/10/2024SE |
| K233764 | SSS-NX (Serum Substitute Supplement-NX)MQL · Traditional | Fujifilm Irvine Scientific | 04/24/2024SE |
| K232125 | V-PvpMQL · Traditional | Vitromed GmbH | 03/20/2024SE |
| K232942 | G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing MediaMQL · Traditional | Gimbo Medical Technology Shenzhen Co., Ltd. | 01/30/2024SE |
| K231370 | Dewin Blastocyst Medium (with HSA and without HSA)MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 08/04/2023SE |
| K222606 | V-HyadaseMQL · Traditional | Vitromed GmbH | 05/26/2023SE |
| K223265 | CryoX Vitrification Freeze Kit / Thaw KitMQL · Traditional | Zhejiang Horizon Medical Technology Co., Ltd. | 05/11/2023SE |
| K220715 | ARTSMedia In Vitro Culture Medium (AM-IVC Medium)MQL · Traditional | Artsmedia Denmark Aps | 02/10/2023SE |
| K223117 | V-Sperm WashMQL · Traditional | Vitromed GmbH | 01/31/2023SE |
| K213293 | V-Hepes PlusMQL · Traditional | Vitromed Langenfeld | 09/14/2022SE |
| K212426 | Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and…MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 06/16/2022SE |
| K212410 | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient MediumMQL · Traditional | Shenzhen Vitavitro Biotech Co., Ltd. | 02/01/2022SE |
| K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUSMQL · Traditional | Vitrolife Sweden AB | 05/14/2021SE |
| K193285 | V-OnestepMQL · Traditional | Vitromed GmbH | 11/20/2020SE |
| K192503 | GM501 Wash with Phenol Red and GentamicinMQL · Special | Hamilton Thorne Incorporated | 11/19/2020SE |
| K200249 | Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA]…MQL · Traditional | Kitazato Corporation | 10/23/2020SE |
| K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing…MQL · Traditional | Shenzhen Vitavitro Biotech Co., Ltd. | 10/16/2020SE |
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAMQL · Traditional | Kitazato Corporation | 08/25/2020SE |
| K192845 | Sperm Freeze, Sperm FridgeMQL · Traditional | Kitazato Corporation | 08/17/2020SE |
| K200680 | Synvitro HyadaseMQL · Special | Origio A/S, A Coopersurgical Company | 07/17/2020SE |
| K192644 | GM501 SpermAir and GM501 SpermActiveMQL · Traditional | Hamilton Thorne Incorporated | 04/23/2020SE |
| K190199 | SepaSperm Washing Solution, SepaSperm SolutionMQL · Traditional | Kitazato Corporation | 09/26/2019SE |
| K191552 | GM501 Mineral OilMQL · Abbreviated | Hamilton Thorne, Inc. | 09/18/2019SE |
| K190383 | GM501 WashMQL · Traditional | Hamilton Thorne, Inc. | 09/05/2019SE |
| K191063 | 1-Step Culture MediumMQL · Traditional | Shenzhen Vitavitro Biotech Co., Ltd. | 08/23/2019SE |
| K183486 | RapidVit Oocyte, RapidWarm OocyteMQL · Traditional | Vitrolife Sweden AB | 07/26/2019SE |
| K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NXMQL · Traditional | Fujifilm Irvine Scientific, Inc. | 06/21/2019SE |
| K182002 | Cumulus RemoverMQL · Traditional | Kitazato Corporation | 10/23/2018SE |
| K180073 | Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw SetMQL · Traditional | Shenzhen Vitavitro Bio-Tech Co., Ltd. | 08/29/2018SE |
| K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit…MQL · Traditional | CooperSurgical, Inc. | 03/02/2018SE |
| K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red…MQL · Traditional | Origio A/S | 03/02/2018SE |
| K171748 | Vitrification Kit and Thawing KitMQL · Traditional | Kitazato Corporation | 12/14/2017SE |
| K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSMQL · Traditional | Origio A/S | 10/13/2017SE |
| K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50MQL · Traditional | Genea Biomedx Pty, Ltd. | 09/28/2017SE |
| K171224 | Arctic Sperm Cryopreservation MediumMQL · Traditional | Irvine Scientific Sales Co., Inc. | 08/31/2017SE |
| K170681 | Continuous Single Culture -NX (CSCM-NX)MQL · Traditional | Irvine Scientific Sales Co., Inc. | 06/08/2017SE |
| K170602 | Continuous Single Culture-NX Complete (CSCM-NXC)MQL · Traditional | Irvine Scientific Sales Co., Inc. | 06/07/2017SE |
| K162409 | Gems Vitrification Set, Gems Warming SetMQL · Traditional | Genea Biomedx Pty, Ltd. | 05/24/2017SE |
| K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst…MQL · Traditional | Genea Biomedx Pty, Ltd. | 05/12/2017SE |
| K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming KitMQL · Special | CooperSurgical, Inc. | 04/04/2017SE |
| K170257 | Sydney IVF Culture OilMQL · Special | William A. Cook Australia Pty. , Ltd. | 02/24/2017SE |
| K160864 | Cryotop Vitrification Kit and Cryotop Thawing KitMQL · Traditional | Kitazato Biopharma Co., Ltd. | 10/07/2016SE |
| K153478 | Sydney IVF Gamete BufferMQL · Traditional | William A. Cook Australia Pty. , Ltd. | 08/15/2016SE |
| K160863 | PBS(-), Phosphate Buffered SalineMQL · Traditional | Kitazato Biopharma Co., Ltd. | 07/28/2016SE |
| K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashMQL · Traditional | Origio A/S | 07/22/2016SE |
| K152717 | Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitMQL · Special | William A. Cook Australia Pty. , Ltd. | 05/06/2016SE |
| K152682 | Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitMQL · Special | Willian A. Cook Australia Pty, Ltd. | 05/05/2016SE |
| K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…MQL · Traditional | Irvine Scientific | 05/04/2016SE |
| K160814 | Sydney IVF Sperm Cryopreservation BufferMQL · Special | William A. Cook Australia Pty. , Ltd. | 04/22/2016SE |
| K160142 | Mineral OilMQL · Traditional | Kitazato Biopharma Co., Ltd. | 04/21/2016SE |
| K152932 | BlastGenMQL · Traditional | Origio A/S | 02/29/2016SE |
| K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…MQL · Special | William A. Cook Australia Pty. , Ltd. | 01/27/2016SE |
| K151367 | Sydney IVF HyaluronidaseMQL · Traditional | William A. Cook Australia Pty. , Ltd. | 01/27/2016SE |
| K152782 | Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf SpermientMQL · Special | William A. Cook Australia Pty. , Ltd. | 12/21/2015SE |
| K150950 | FreezeKit Cleave , ThawKit CleaveMQL · Traditional | Vitrolife Sweden AB | 12/21/2015SE |
| K152904 | Sydney Ivf Embryo Biopsy MediumMQL · Special | William A. Cook Australia Pty. , Ltd. | 12/03/2015SE |
| K152440 | Sydney IVF PVPMQL · Special | Willam A. Cook Australia Pty, Ltd. | 09/23/2015SE |
| K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming KitMQL · Special | William A. Cook Australia Pty. , Ltd. | 08/27/2015SE |
| K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA…MQL · Traditional | Life Global Group, LLC | 02/17/2015SE |
| K143498 | LifeGlobal Global HPMQL · Traditional | Life Global Group, LLC | 01/20/2015SE |
| K133568 | G-TlMQL · Traditional | Vitrolife, Inc. | 07/16/2014SE |
| K140317 | EmbryogenMQL · Traditional | Origio A/S | 06/16/2014SE |
| K133912 | Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio Sequential Cleav…MQL · Traditional | Origio A/S | 05/14/2014SE |
| K133387 | Origio(R) Sequential Blast TM; Origio(R) Sequential Blast TM with Phenol RedMQL · Traditional | Origio A/S | 04/29/2014SE |
| K133707 | Sage 1-STEP with Human Serum Albumin, Sage 1-STEP with Serum Protein SupplementsMQL · Traditional | Origio A/S | 04/16/2014SE |
| K113786 | Spermfreeze SolutionMQL · Traditional | Vitrolife Sweden AB | 10/26/2012SE |
| K120136 | EmbryogenMQL · Traditional | Origio A/S | 09/26/2012SE |
| K121572 | Continuous Single Culture CompleteMQL · Traditional | Irvine Scientific Sales Co., Inc. | 07/19/2012SE |
| K121128 | Multipurpose Handling MediumMQL · Traditional | Irvine Scientific Sales Co., Inc. | 06/06/2012SE |
| K112083 | Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total, HTF Total W/HepesMQL · Traditional | <Genx> Intl., Inc. | 05/03/2012SE |
| K092963 | Global Blastocyst Vitrification Kit & Vitrification Thawing Kit - Based on S3MQL · Traditional | Genx Intl., Inc. | 01/14/2011SE |
| K101003 | Rapidvit Blast, Rapidwarm BlastMQL · Traditional | Vitrolife Sweden AB | 12/10/2010SE |
| K100367 | Medicult Vitrification Cooling/Warming, Model Ref: 1228, 1229MQL · Traditional | Origio A/S | 08/27/2010SE |
| K092107 | Vitriblast, Thermoblast, Model VB-010, TB-010MQL · Traditional | Nidacon International AB | 06/15/2010SE |
| K092667 | Global Dmso Blastocyst Vitrification Kit and Warming KitMQL · Traditional | Genx Intl., Inc. | 06/03/2010SE |
| K092578 | Lifeglobal Protein SupplementMQL · Traditional | Genx Intl., Inc. | 04/05/2010SE |
| K093273 | Vit Kit - Freeze and ThawMQL · Traditional | Irvine Scientific Sales Co., Inc. | 03/03/2010SE |
| K082363 | Cook Sydney Ivf Blastocyst Vitrification (K-SIBV-5000), Warming (K-SIBW-5000) KitsMQL · Traditional | William A. Cook Australia Pty. , Ltd. | 04/29/2009SE |
| K083509 | Lifeglobal Human Serum Albumin LG HsaMQL · Traditional | Genx Intl., Inc. | 04/24/2009SE |
| K080172 | Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref…MQL · Traditional | Medicult A/S | 12/18/2008SE |
| K080446 | Rapidvit and Rapidwarm CleaveMQL · Traditional | Vitrolife Sweden AB | 11/26/2008SE |
| K073522 | Vitrification Kit & Vitrification Warming KitMQL · Traditional | Sage In-Vitro Fertilization, Inc. | 10/10/2008SE |
| K081639 | Icsi CumulaseMQL · Traditional | Medicult A/S | 09/19/2008SE |
| K081115 | G-Mops G5 SeriesMQL · Traditional | Vitrolife Sweden AB | 09/17/2008SE |
| K081117 | G-2 V5MQL · Traditional | Vitrolife Sweden AB | 09/16/2008SE |
| K081114 | G-1 V5MQL · Traditional | Vitrolife Sweden AB | 09/16/2008SE |
| K080473 | Embryoassist and Embryoassist with Phenol RedMQL · Traditional | Medicult A/S | 09/03/2008SE |
| K081116 | G-Ivf G5 SeriesMQL · Traditional | Vitrolife Sweden AB | 09/02/2008SE |
| K072609 | Single Step MediumMQL · Traditional | Irvine Scientific Sales Co., Inc. | 02/12/2008SE |
| K072608 | Lyophilized Multiblast Medium KitMQL · Traditional | Irvine Scientific Sales Co., Inc. | 01/30/2008SE |
| K072607 | Lyophilized Early Cleavage Medium (Ecm) KitMQL · Traditional | Irvine Scientific Sales Co., Inc. | 01/25/2008SE |
| K070135 | Vitrifreeze Medium; Vitrithaw MediumMQL · Traditional | Fertipro NV | 08/16/2007SE |
| K070689 | LG Sperm FreezingMQL · Traditional | Genx Intl., Inc. | 07/03/2007SE |
| K061309 | EmbryoassistMQL · Traditional | Medicult A/S | 02/08/2007SE |
| K061145 | SpermslowMQL · Traditional | Medicult A/S | 10/02/2006SE |
| K061371 | Sydney Ivf Sperm Cryopreservation BufferMQL · Traditional | Cook Urological, Inc. | 08/17/2006SE |
| K060983 | Biopsy Medium, Model Ref 1062MQL · Traditional | Medicult A/S | 07/28/2006SE |
| K053646 | Invitro Maturation MediaMQL · Traditional | Sage In-Vitro Fertilization, Inc. | 07/14/2006SE |
| K053552 | Global Fertilization, Embryo Culture and Transfer MediaMQL · Traditional | <Genx> Intl., Inc. | 05/19/2006SE |
| K060699 | Synvitro Cumulase (Hyaluronidase Medium)MQL · Traditional | Medicult A/S | 05/10/2006SE |
| K053551 | Micromanipulation Media System, LG Hyaluronidase and LG Paraffin OilMQL · Traditional | <Genx> Intl., Inc. | 05/09/2006SE |
| K060168 | Vitrification Freeze Kit, Vitrification Thaw KitMQL · Traditional | Irvine Scientific Sales Co., Inc. | 04/24/2006SE |
| K053494 | Oil for Tissue Culture, Gradient System and SpermfreezeMQL · Traditional | Fertipro NV | 03/23/2006SE |
| K042495 | CumulaseMQL · Traditional | Halozyme Therapeutics, Inc. | 04/14/2005SE |
| K043116 | ICSI-100MQL · Traditional | Vitrolife Sweden AB | 01/13/2005SE |
| K041284 | Medicult Ivm SystemMQL · Traditional | Medicult A/S | 11/22/2004SE |
| K040530 | Media Culture SystemMQL · Traditional | <Genx> Intl., Inc. | 06/25/2004SE |
| K033101 | G-PgdMQL · Traditional | Vitrolife Sweden AB | 05/07/2004SE |
| K032877 | G-OocyteMQL · Traditional | Vitrolife Sweden AB | 05/07/2004SE |
| K032155 | G-Thawkit BlastMQL · Traditional | Vitrolife AB | 05/07/2004SE |
| K032154 | G-Freezekit BlastMQL · Traditional | Vitrolife AB | 05/07/2004SE |
| K034063 | Multiblast MediumMQL · Traditional | Irvine Scientific Sales Co., Inc. | 04/26/2004SE |
| K031304 | Sydney Ivf PVPMQL · Traditional | Cook Urological, Inc. | 03/23/2004SE |
| K033462 | Early Cleavage Medium (Ecm)MQL · Traditional | Irvine Scientific Sales Co., Inc. | 01/15/2004SE |
| K032887 | Phenol Red Stock SolutionMQL · Traditional | Irvine Scientific Sales Co., Inc. | 12/19/2003SE |
| K030441 | Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw KitMQL · Traditional | Cook Ob/Gyn | 08/29/2003SE |
| K030490 | ISM1+, IMS2+, and Utm+MQL · Traditional | Medicult A/S | 08/20/2003SE |
| K031486 | Blastfreeze and BlastthawMQL · Traditional | Medicult A/S | 06/27/2003SE |
| K031228 | Synvitro HyadaseMQL · Traditional | Medicult A/S | 06/24/2003SE |
| K031015 | EmbryoglueMQL · Traditional | Vitrolife Sweden AB | 06/23/2003SE |
| K030850 | Enhance Human Serum AlbuminMQL · Traditional | Conception Technologies | 04/08/2003SE |
| K030117 | Enhance Sperm FreezeMQL · Traditional | Conception Technology, Inc. | 03/20/2003SE |
| K024290 | Promotor Final Rinse Sperm Wash MediumMQL · Traditional | Ceres Fertility, Inc. | 03/03/2003SE |
| K030116 | Enhance-S Plus HMQL · Special | Conception Technology, Inc. | 02/12/2003SE |
| K023850 | Sydney Ivf Embryo Biopsy MediumMQL · Traditional | Cook Ob/Gyn | 01/22/2003SE |
| K023222 | Isocare One Step Sperm Processing Medium Cat# 2207-12MQL · Traditional | Invitrocare, Inc. | 12/26/2002SE |
| K023353 | Sydney Ivf HyaluronidaseMQL · Traditional | Cook Urological, Inc. | 12/20/2002SE |
| K023717 | Sperm Wash Medium with GentamicinMQL · Traditional | Conception Technologies | 12/13/2002SE |
| K023655 | Enhance HTF Medium with HepesMQL · Traditional | Conception Technologies | 12/13/2002SE |
| K023403 | Spermgrad, Models 10022/10063MQL · Traditional | Vitrolife Sweden AB | 12/13/2002SE |
| K023033 | Allgrad Wash (Herpes Buffered Washing Medium)MQL · Traditional | <Genx> Intl., Inc. | 11/26/2002SE |
| K023206 | Sperm CryoprotecMQL · Traditional | Nidacon International AB | 11/08/2002SE |
| K023106 | PromotorMQL · Traditional | Ceres Fertility, Inc. | 11/05/2002SE |
| K022931 | Hyaluronidase SolutionMQL · Traditional | Irvine Scientific Sales Co., Inc. | 11/04/2002SE |
| K022295 | G-Rinse, Model 10031MQL · Traditional | Vitrolife Sweden AB | 09/12/2002SE |
| K022247 | G-Sperm, Model 10032MQL · Traditional | Vitrolife Sweden AB | 09/06/2002SE |
| K022245 | G-Fert, Model 10033MQL · Traditional | Vitrolife Sweden AB | 09/06/2002SE |
| K022244 | G-1 Version 3, Model 10048MQL · Traditional | Vitrolife Sweden AB | 09/06/2002SE |
| K021896 | Hsa-Solution, Model 10034/10064MQL · Traditional | Vitrolife Sweden AB | 09/06/2002SE |
| K021894 | G-Mm, Model 10038MQL · Traditional | Vitrolife Sweden AB | 09/06/2002SE |
| K021893 | G-Mops, Model 10030MQL · Traditional | Vitrolife Sweden AB | 09/06/2002SE |
| K021890 | G-2 Version 3, Model 10049MQL · Traditional | Vitrolife Sweden AB | 09/06/2002SE |
| K022590 | PVP (Polyvinylpyrrolidone)MQL · Traditional | <Genx> Intl., Inc. | 08/30/2002SE |
| K022547 | Acidified Tyrodes SolutionMQL · Traditional | <Genx> Intl., Inc. | 08/28/2002SE |
| K022443 | SpermassistMQL · Traditional | Nidacon International AB | 08/28/2002SE |
| K022352 | HTF Plus with Hepes (HTF with Non-Essential Amino Acids)MQL · Traditional | <Genx> Intl., Inc. | 08/28/2002SE |
| K022334 | HTF Plus - HTF with Non-Essential Amino AcidsMQL · Traditional | <Genx> Intl., Inc. | 08/28/2002SE |
| K022330 | Allgrad 45 and 90 Cell Separation MediaMQL · Traditional | <Genx> Intl., Inc. | 08/26/2002SE |
| K022335 | Allgrad and ALLGRAD100MQL · Traditional | <Genx> Intl., Inc. | 08/23/2002SE |
| K022332 | Lite Mineral OilMQL · Traditional | <Genx> Intl., Inc. | 08/23/2002SE |
| K022002 | Sydney Ivf Culture OilMQL · Traditional | Cook Urological, Inc. | 08/12/2002SE |
| K021358 | Embryo Biopsy MediumMQL · Traditional | Irvine Scientific Sales Co., Inc. | 07/05/2002SE |
| K020490 | PBS, PBSW with Cations and Phenol RedMQL · Traditional | Conception Technologies | 03/28/2002SE |
| K013518 | Embryo Freeze Medium, Embryo Thaw MediumMQL · Traditional | Irvine Scientific Sales Co., Inc. | 01/18/2002SE |
| K011607 | SpermcatchMQL · Traditional | Nidacon International AB | 08/10/2001SE |
| K012123 | NidoilMQL · Traditional | Nidacon International AB | 08/03/2001SE |
| K011938 | Oil for Embryo CultureMQL · Traditional | Irvine Scientific Sales Co., Inc. | 07/18/2001SE |
| K011606 | Puresperm BufferMQL · Traditional | Nidacon International AB | 07/12/2001SE |
| K011573 | Hyaluronidase in HTF Medium; Hyaluronidase in Ebss MediumMQL · Traditional | Conception Technologies | 07/02/2001SE |
| K011481 | 10% PVP; 10% PVP in Ebss SolutionMQL · Traditional | Conception Technologies | 07/02/2001SE |
| K011346 | ReadyswimMQL · Traditional | Nidacon International AB | 06/28/2001SE |
| K011462 | Oil for Tissue CultureMQL · Traditional | Conception Technologies | 06/13/2001SE |
| K011157 | Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw KitMQL · Traditional | Cook Urological, Inc. | 05/03/2001SE |
| K010183 | Global by <Genx> Blastocyst MediaMQL · Traditional | <Genx> Intl., Inc. | 05/02/2001SE |
| K003404 | Suprasperm SystemMQL · Traditional | Medicult A/S | 03/22/2001SE |
| K003163 | Synvitro FlushMQL · Traditional | Medicult A/S | 03/22/2001SE |
| K003156 | Blastassist SystemMQL · Traditional | Medicult A/S | 03/22/2001SE |
| K003751 | Hyaluronidase Reagent, Model CAT#2212MQL · Traditional | Invitrocare, Inc. | 01/17/2001SE |
| K003278 | Complete Human Tubal Fluid (HTF) with Serum Substitute Supplement, Model 9922MQL · Traditional | Irvine Scientific Sales Co., Inc. | 01/17/2001SE |
| K003734 | Serum Protein SubstituteMQL · Special | Sage Biopharma | 12/21/2000SE |
| K003448 | Dextran Serum Supplement (DSS), Model 9301MQL · Traditional | Irvine Scientific Sales Co., Inc. | 12/07/2000SE |
| K002630 | Puresperm WashMQL · Traditional | Nidacon International AB | 11/21/2000SE |
| K002623 | Puresperm 40 and Puresperm 80MQL · Traditional | Nidacon International AB | 11/20/2000SE |
| K002836 | Media for Gamete Preparation and Embryo CultureMQL · Special | Sage Biopharma | 10/03/2000SE |
| K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization…MQL · Traditional | Cook Ob/Gyn | 09/18/2000SE |
| K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient KitMQL · Traditional | Cook Ob/Gyn | 09/13/2000SE |
| K001967 | Pvp-Polyvinylpyrrolidone Reagent, Model CAT#2210MQL · Traditional | Invitrocare, Inc. | 08/14/2000SE |
| K991279 | Medi-Cult Universal Ivf-MediumMQL · Traditional | Medicult A/S | 07/20/2000SE |
| K000619 | Scandinavian Ivf Sciences AB, G2.2MQL · Traditional | Vitrolife AB/Scandinavian Ivf Sciences AB | 06/27/2000SE |
| K991334 | Medi-Cult Hyaluronidase;MQL · Traditional | Medicult A/S | 06/20/2000SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3298-2024 Class II | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of…Low concentration of sodium pyruvate in the wash could compromise gamete development | CooperSurgical, Inc. | 02/16/2024Open, Classified |
| Z-3297-2024 Class II | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of…Low concentration of sodium pyruvate in the wash could compromise gamete development | CooperSurgical, Inc. | 02/16/2024Open, Classified |
| Z-3296-2024 Class II | Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa…Low concentration of sodium pyruvate in the wash could compromise gamete development | CooperSurgical, Inc. | 02/16/2024Open, Classified |
| Z-1089-2024 Class II | global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100…The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues… | CooperSurgical, Inc. | 12/20/2023Open, Classified |
| Z-0998-2024 Class II | Sperm separation media are used to separate motile sperm from other constituents of semen.The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit… | Fujifilm Irvine Scientific, Inc. | 11/02/2023Open, Classified |
| Z-1348-2023 Class II | Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo…It has come to CooperSurgical's attention that the affected Product may contain a medium other than the… | CooperSurgical, Inc. | 02/13/2023Open, Classified |
| Z-1314-2023 Class II | Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. | Fujifilm Irvine Scientific, Inc. | 01/16/2023Open, Classified |
| Z-1044-2023 Class II | BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage…The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the… | CooperSurgical, Inc. | 12/15/2022Open, Classified |
| Z-1421-2022 Class II | LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055There was translation error in the Spanish version of the IFU where the Spanish version instructs the user… | CooperSurgical, Inc. | 06/13/2022Open, Classified |
| Z-0249-2022 Class II | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification…Due to a component in kit being labeled with the incorrect Expiration Date | Fujifilm Irvine Scientific, Inc. | 09/08/2021Open, Classified |
| Z-0248-2022 Class II | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification…Due to a component in kit being labeled with the incorrect Expiration Date | Fujifilm Irvine Scientific, Inc. | 09/08/2021Open, Classified |
| Z-0100-2021 Class II | MediCult Vitrification Cooling Media, Model Number 12284001FThere is a discrepancy between the printing on the Product Tyvek label of the individual component… | CooperSurgical, Inc. | 09/08/2020Terminated |
| Z-2851-2016 Class III | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium…Products contain international package insert and not the correct USA package insert | CooperSurgical, Inc. | 08/25/2016Terminated |
| Z-2850-2016 Class III | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium…Products contain international package insert and not the correct USA package insert | CooperSurgical, Inc. | 08/25/2016Terminated |
| Z-1324-2012 | Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C…Cook Medical is recalling Sydney IVF Culture Oil due to a number of recent customer complaints that have… | Cook, Inc. | 02/15/2012Terminated |