Panels › Obstetrics/Gynecology › Product code MQL · Class 2
Media, Reproductive
Regulation 884.6180
3510(k)s in 12 months (260 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
Top companies in MQL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 2, 2018 | K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311) Origio A/S, DK | MQL |
| Dec 14, 2017 | K171748 | Vitrification Kit and Thawing Kit Kitazato Corporation, JP | MQL |
| Oct 13, 2017 | K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS Origio A/S, DK | MQL |
| Sep 28, 2017 | K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 Genea Biomedx Pty, Ltd., AU | MQL |
| Aug 31, 2017 | K171224 | Arctic Sperm Cryopreservation Medium Irvine Scientific Sales Co., Inc. | MQL |
| Jun 8, 2017 | K170681 | Continuous Single Culture -NX (CSCM-NX) Irvine Scientific Sales Co., Inc. | MQL |
| Jun 7, 2017 | K170602 | Continuous Single Culture-NX Complete (CSCM-NXC) Irvine Scientific Sales Co., Inc. | MQL |
| May 24, 2017 | K162409 | Gems Vitrification Set, Gems Warming Set Genea Biomedx Pty, Ltd., AU | MQL |
| May 12, 2017 | K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase Genea Biomedx Pty, Ltd., AU | MQL |
| Apr 4, 2017 | K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming Kit CooperSurgical, Inc. | MQL |
| Feb 24, 2017 | K170257 | Sydney IVF Culture Oil William A. Cook Australia Pty. , Ltd., AU | MQL |
| Oct 7, 2016 | K160864 | Cryotop Vitrification Kit and Cryotop Thawing Kit Kitazato Biopharma Co., Ltd., JP | MQL |
| Aug 15, 2016 | K153478 | Sydney IVF Gamete Buffer William A. Cook Australia Pty. , Ltd., AU | MQL |
| Jul 28, 2016 | K160863 | PBS(-), Phosphate Buffered Saline Kitazato Biopharma Co., Ltd., JP | MQL |
| Jul 22, 2016 | K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash Origio A/S, DK | MQL |
| May 6, 2016 | K152717 | Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit William A. Cook Australia Pty. , Ltd., AU | MQL |
| May 5, 2016 | K152682 | Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit Willian A. Cook Australia Pty, Ltd., AU | MQL |
| May 4, 2016 | K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vi Irvine Scientific | MQL |
| Apr 22, 2016 | K160814 | Sydney IVF Sperm Cryopreservation Buffer William A. Cook Australia Pty. , Ltd., AU | MQL |
| Apr 21, 2016 | K160142 | MINERAL OIL Kitazato Biopharma Co., Ltd., JP | MQL |
| Feb 29, 2016 | K152932 | BlastGen Origio A/S, DK | MQL |
| Jan 27, 2016 | K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Med William A. Cook Australia Pty. , Ltd., AU | MQL |
| Jan 27, 2016 | K151367 | Sydney IVF Hyaluronidase William A. Cook Australia Pty. , Ltd., AU | MQL |
| Dec 21, 2015 | K152782 | SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT William A. Cook Australia Pty. , Ltd., AU | MQL |
| Dec 21, 2015 | K150950 | FreezeKit Cleave , ThawKit Cleave Vitrolife Sweden AB | MQL |
| Dec 3, 2015 | K152904 | SYDNEY IVF EMBRYO BIOPSY MEDIUM William A. Cook Australia Pty. , Ltd., AU | MQL |
| Sep 23, 2015 | K152440 | Sydney IVF PVP Willam A. Cook Australia Pty, Ltd., AU | MQL |
| Aug 27, 2015 | K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit William A. Cook Australia Pty. , Ltd., AU | MQL |
| Feb 17, 2015 | K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA Life Global Group, LLC | MQL |
| Jan 20, 2015 | K143498 | LifeGlobal Global HP Life Global Group, LLC | MQL |
| Jul 16, 2014 | K133568 | G-TL Vitrolife, Inc. | MQL |
| Jun 16, 2014 | K140317 | EMBRYOGEN Origio A/S, DK | MQL |
| May 14, 2014 | K133912 | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO Origio A/S, DK | MQL |
| Apr 29, 2014 | K133387 | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED Origio A/S, DK | MQL |
| Apr 16, 2014 | K133707 | SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS Origio A/S, DK | MQL |
| Oct 26, 2012 | K113786 | SPERMFREEZE SOLUTION Vitrolife Sweden AB, SE | MQL |
| Sep 26, 2012 | K120136 | EMBRYOGEN Origio A/S | MQL |
| Jul 19, 2012 | K121572 | CONTINUOUS SINGLE CULTURE COMPLETE Irvine Scientific Sales Co., Inc. | MQL |
| Jun 6, 2012 | K121128 | MULTIPURPOSE HANDLING MEDIUM Irvine Scientific Sales Co., Inc. | MQL |
| May 3, 2012 | K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES <Genx> Intl., Inc. | MQL |
| Jan 14, 2011 | K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 Genx Intl., Inc. | MQL |
| Dec 10, 2010 | K101003 | RAPIDVIT BLAST, RAPIDWARM BLAST Vitrolife Sweden AB, SE | MQL |
| Aug 27, 2010 | K100367 | MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 Origio A/S | MQL |
| Jun 15, 2010 | K092107 | VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 Nidacon International AB | MQL |
| Jun 3, 2010 | K092667 | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT Genx Intl., Inc. | MQL |
| Apr 5, 2010 | K092578 | LIFEGLOBAL PROTEIN SUPPLEMENT Genx Intl., Inc. | MQL |
| Mar 3, 2010 | K093273 | VIT KIT - FREEZE AND THAW Irvine Scientific Sales Co., Inc. | MQL |
| Apr 29, 2009 | K082363 | COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS William A. Cook Australia Pty. , Ltd., AU | MQL |
| Apr 24, 2009 | K083509 | LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA Genx Intl., Inc. | MQL |
| Dec 18, 2008 | K080172 | BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 Medicult A/S | MQL |
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