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 Kitazato Corporation.

259
Total
259
Cleared
158d
Avg days
1987
Since
259 devices
49–72 of 259
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 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 Apr 04, 2017
SAGE Vitrification Kit and SAGE Vitrification Warming Kit
K170560
CooperSurgical, Inc.
Obstetrics & Gynecology · 36d
Cleared Dec 21, 2015
FreezeKit Cleave , ThawKit Cleave
K150950
Vitrolife Sweden AB
Obstetrics & Gynecology · 257d
Cleared Oct 26, 2012
SPERMFREEZE SOLUTION
K113786
Vitrolife Sweden AB
Obstetrics & Gynecology · 309d
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 Dec 10, 2010
RAPIDVIT BLAST, RAPIDWARM BLAST
K101003
Vitrolife Sweden AB
Obstetrics & Gynecology · 242d
Cleared Mar 03, 2010
VIT KIT - FREEZE AND THAW
K093273
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 135d
Cleared Nov 26, 2008
RAPIDVIT AND RAPIDWARM CLEAVE
K080446
Vitrolife Sweden AB
Obstetrics & Gynecology · 281d
Cleared Sep 17, 2008
G-MOPS G5 SERIES
K081115
Vitrolife Sweden AB
Obstetrics & Gynecology · 152d
Cleared Sep 16, 2008
G-1 V5
K081114
Vitrolife Sweden AB
Obstetrics & Gynecology · 151d
Cleared Sep 16, 2008
G-2 V5
K081117
Vitrolife Sweden AB
Obstetrics & Gynecology · 151d
Cleared Sep 02, 2008
G-IVF G5 SERIES
K081116
Vitrolife Sweden AB
Obstetrics & Gynecology · 137d
Cleared Feb 12, 2008
SINGLE STEP MEDIUM
K072609
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 148d
Cleared Jan 30, 2008
LYOPHILIZED MULTIBLAST MEDIUM KIT
K072608
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 135d
Cleared Jan 25, 2008
LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
K072607
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 130d
Cleared Aug 17, 2006
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371
Cook Urological, Inc.
Obstetrics & Gynecology · 92d
Cleared Apr 24, 2006
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
K060168
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 91d
Cleared Jan 13, 2005
ICSI-100
K043116
Vitrolife Sweden AB
Obstetrics & Gynecology · 64d
Cleared May 07, 2004
G-OOCYTE
K032877
Vitrolife Sweden AB
Obstetrics & Gynecology · 235d