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
97–120 of 260
Cleared Dec 18, 2008
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
K080172
Medicult A/S
Obstetrics & Gynecology · 329d
Cleared Nov 26, 2008
RAPIDVIT AND RAPIDWARM CLEAVE
K080446
Vitrolife Sweden AB
Obstetrics & Gynecology · 281d
Cleared Sep 19, 2008
ICSI CUMULASE
K081639
Medicult A/S
Obstetrics & Gynecology · 100d
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 03, 2008
EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED
K080473
Medicult A/S
Obstetrics & Gynecology · 195d
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 Jul 03, 2007
LG SPERM FREEZING
K070689
Intl., Inc.
Obstetrics & Gynecology · 112d
Cleared Feb 08, 2007
EMBRYOASSIST
K061309
Medicult A/S
Obstetrics & Gynecology · 274d
Cleared Oct 02, 2006
SPERMSLOW
K061145
Medicult A/S
Obstetrics & Gynecology · 160d
Cleared Aug 17, 2006
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371
Cook Urological, Inc.
Obstetrics & Gynecology · 92d
Cleared Jul 28, 2006
BIOPSY MEDIUM, MODEL REF 1062
K060983
Medicult A/S
Obstetrics & Gynecology · 109d
Cleared May 19, 2006
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
K053552
Intl., Inc.
Obstetrics & Gynecology · 150d
Cleared May 10, 2006
SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)
K060699
Medicult A/S
Obstetrics & Gynecology · 55d
Cleared May 09, 2006
MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL
K053551
Intl., Inc.
Obstetrics & Gynecology · 140d
Cleared Apr 24, 2006
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
K060168
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 14, 2005
CUMULASE
K042495
Halozyme Therapeutics, Inc.
Obstetrics & Gynecology · 212d
Cleared Jan 13, 2005
ICSI-100
K043116
Vitrolife Sweden AB
Obstetrics & Gynecology · 64d
Cleared Nov 22, 2004
MEDICULT IVM SYSTEM
K041284
Medicult A/S
Obstetrics & Gynecology · 193d
Cleared Jun 25, 2004
MEDIA CULTURE SYSTEM
K040530
Intl., Inc.
Obstetrics & Gynecology · 116d