MQL · Class II · 21 CFR 884.6180

FDA Product Code MQL: Media, Reproductive

Leading manufacturers include Irvine Scientific Sales Co., Inc., Vitrolife Sweden AB and Medicult A/S.

260
Total
260
Cleared
158d
Avg days
1987
Since
260 devices
49–72 of 260
Cleared Aug 29, 2018
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
K180073
Shenzhen Vitavitro Bio-Tech Co., Ltd.
Obstetrics & Gynecology · 232d
Cleared Mar 02, 2018
ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)
K173624
Origio A/S
Obstetrics & Gynecology · 98d
Cleared Mar 02, 2018
SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
K173731
CooperSurgical, Inc.
Obstetrics & Gynecology · 86d
Cleared Dec 14, 2017
Vitrification Kit and Thawing Kit
K171748
Kitazato Corporation
Obstetrics & Gynecology · 184d
Cleared Oct 13, 2017
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
K172197
Origio A/S
Obstetrics & Gynecology · 84d
Cleared Sep 28, 2017
Gems Oocyte Retrieval Buffer ORB-20, ORB-50
K170498
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 223d
Cleared Aug 31, 2017
Arctic Sperm Cryopreservation Medium
K171224
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 127d
Cleared Jun 08, 2017
Continuous Single Culture -NX (CSCM-NX)
K170681
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 94d
Cleared Jun 07, 2017
Continuous Single Culture-NX Complete (CSCM-NXC)
K170602
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 98d
Cleared May 24, 2017
Gems Vitrification Set, Gems Warming Set
K162409
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 268d
Cleared May 12, 2017
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
K161261
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 373d
Cleared Apr 04, 2017
SAGE Vitrification Kit and SAGE Vitrification Warming Kit
K170560
CooperSurgical, Inc.
Obstetrics & Gynecology · 36d
Cleared Feb 24, 2017
Sydney IVF Culture Oil
K170257
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 28d
Cleared Oct 07, 2016
Cryotop Vitrification Kit and Cryotop Thawing Kit
K160864
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 192d
Cleared Aug 15, 2016
Sydney IVF Gamete Buffer
K153478
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 257d
Cleared Jul 28, 2016
PBS(-), Phosphate Buffered Saline
K160863
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 121d
Cleared Jul 22, 2016
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
K153267
Origio A/S
Obstetrics & Gynecology · 253d
Cleared May 06, 2016
Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
K152717
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 228d
Cleared May 05, 2016
Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit
K152682
Willian A. Cook Australia Pty, Ltd.
Obstetrics & Gynecology · 230d
Cleared May 04, 2016
Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit
K160006
Irvine Scientific
Obstetrics & Gynecology · 121d
Cleared Apr 22, 2016
Sydney IVF Sperm Cryopreservation Buffer
K160814
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 29d
Cleared Apr 21, 2016
MINERAL OIL
K160142
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 91d
Cleared Feb 29, 2016
BlastGen
K152932
Origio A/S
Obstetrics & Gynecology · 147d
Cleared Jan 27, 2016
Sydney IVF Hyaluronidase
K151367
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 251d