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
193–216 of 260
Cleared Sep 24, 1999
PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA
K991381
Pacific Andrology, Inc.
Obstetrics & Gynecology · 156d
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 Sep 09, 1999
SPERM WASHING MEDIA
K991022
Intl., Inc.
Obstetrics & Gynecology · 164d
Cleared Jul 26, 1999
ENHANCE-S PLUS
K991322
Conception Technology, Inc.
Obstetrics & Gynecology · 98d
Cleared Jul 19, 1999
FERTILIZATION MEDIA-HTF
K991173
Intl., Inc.
Obstetrics & Gynecology · 103d
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
Cleared Jan 14, 1999
MODIFICATION OF PURESPERM
K984172
Nidacon International AB
Obstetrics & Gynecology · 55d
Cleared Jun 23, 1998
PURESPERM
K980814
Nidacon International AB
Obstetrics & Gynecology · 112d
Cleared Jul 03, 1997
ISOLATE
K971809
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 49d
Cleared Feb 02, 1987
SPERM SELECT(TM)
K864524
Pharmacia, Inc.
Pathology · 77d