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
73–96 of 260
Cleared Jan 27, 2016
Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium
K153290
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 75d
Cleared Dec 21, 2015
FreezeKit Cleave , ThawKit Cleave
K150950
Vitrolife Sweden AB
Obstetrics & Gynecology · 257d
Cleared Dec 21, 2015
SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
K152782
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 87d
Cleared Dec 03, 2015
SYDNEY IVF EMBRYO BIOPSY MEDIUM
K152904
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 63d
Cleared Sep 23, 2015
Sydney IVF PVP
K152440
Willam A. Cook Australia Pty, Ltd.
Obstetrics & Gynecology · 27d
Cleared Aug 27, 2015
COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
K143724
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 241d
Cleared Feb 17, 2015
LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
K142991
Life Global Group, LLC
Obstetrics & Gynecology · 124d
Cleared Jan 20, 2015
LifeGlobal Global HP
K143498
Life Global Group, LLC
Obstetrics & Gynecology · 41d
Cleared Jul 16, 2014
G-TL
K133568
Vitrolife, Inc.
Obstetrics & Gynecology · 238d
Cleared Jun 16, 2014
EMBRYOGEN
K140317
Origio A/S
Obstetrics & Gynecology · 126d
Cleared May 14, 2014
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO
K133912
Origio A/S
Obstetrics & Gynecology · 142d
Cleared Apr 29, 2014
ORIGIO(R) SEQUENTIAL BLAST TM
K133387
Origio A/S
Obstetrics & Gynecology · 175d
Cleared Apr 16, 2014
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
K133707
Origio A/S
Obstetrics & Gynecology · 133d
Cleared Oct 26, 2012
SPERMFREEZE SOLUTION
K113786
Vitrolife Sweden AB
Obstetrics & Gynecology · 309d
Cleared Sep 26, 2012
EMBRYOGEN
K120136
Origio A/S
Obstetrics & Gynecology · 253d
Cleared Jul 19, 2012
CONTINUOUS SINGLE CULTURE COMPLETE
K121572
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 51d
Cleared Jun 06, 2012
MULTIPURPOSE HANDLING MEDIUM
K121128
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 54d
Cleared May 03, 2012
LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
K112083
Intl., Inc.
Obstetrics & Gynecology · 287d
Cleared Jan 14, 2011
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
K092963
Intl., Inc.
Obstetrics & Gynecology · 476d
Cleared Dec 10, 2010
RAPIDVIT BLAST, RAPIDWARM BLAST
K101003
Vitrolife Sweden AB
Obstetrics & Gynecology · 242d
Cleared Jun 03, 2010
GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
K092667
Intl., Inc.
Obstetrics & Gynecology · 276d
Cleared Apr 05, 2010
LIFEGLOBAL PROTEIN SUPPLEMENT
K092578
Intl., Inc.
Obstetrics & Gynecology · 227d
Cleared Mar 03, 2010
VIT KIT - FREEZE AND THAW
K093273
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 135d
Cleared Apr 24, 2009
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
K083509
Intl., Inc.
Obstetrics & Gynecology · 149d