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
97–120 of 259
Cleared Jan 17, 2001
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
K003278
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 07, 2000
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
K003448
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 31d
Cleared Sep 18, 2000
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
K002385
Cook Ob/Gyn
Obstetrics & Gynecology · 45d
Cleared Sep 13, 2000
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
K002383
Cook Ob/Gyn
Obstetrics & Gynecology · 40d
Cleared May 17, 2000
IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
K991348
Vitrolife Sweden AB
Obstetrics & Gynecology · 394d
Cleared Mar 13, 2000
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
K000309
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 41d
Cleared Feb 25, 2000
OVOIL-150, MODEL 5002
K991351
Vitrolife Sweden AB
Obstetrics & Gynecology · 312d
Cleared Feb 24, 2000
PH-100, MODEL 2104
K991346
Vitrolife Sweden AB
Obstetrics & Gynecology · 311d
Cleared Feb 18, 2000
ASP-100, MODEL 2100
K991345
Vitrolife Sweden AB
Obstetrics & Gynecology · 305d
Cleared Dec 06, 1999
TYRODE'S SOLUTION-ACIDIFIED
K991339
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 231d
Cleared Sep 14, 1999
MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI
K991419
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 144d
Cleared Jul 14, 1999
BOVINE SERUM ALBUMIN (BSA)
K991338
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 86d
Cleared Jul 14, 1999
PVP (POLYVINYLPYRROLIDONE)
K991343
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 86d
Cleared Jul 08, 1999
SPERM MAINTENANCE MEDIUM WITH GLYCEROL
K991337
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 80d
Cleared Jul 08, 1999
ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION
K991341
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 80d
Cleared Jul 08, 1999
PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION
K991342
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 80d
Cleared Jul 02, 1999
MODIFIED HAM'S F-10 WITH ALBUMIN
K991420
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 70d
Cleared Jul 02, 1999
FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)
K991421
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 70d
Cleared Apr 26, 1999
SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM
K983588
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 195d
Cleared Apr 23, 1999
SYNTHETIC SERUM SUBSTITUTE (SSS)
K983579
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 192d
Cleared Feb 18, 1999
BLASTOCYST MEDIUM
K983580
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 128d
Cleared Feb 18, 1999
HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI
K983586
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 128d
Cleared Feb 18, 1999
P-1 (PREIMPLANTATION STAGE ONE) MEDIUM
K983589
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 128d
Cleared Feb 08, 1999
HUMAN SERUM ALBUMIN (HSA)
K983584
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 118d