Intl., Inc. - FDA 510(k) Cleared Devices
Recent clearances: LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES, GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3, GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
32
Total
32
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intl., Inc.
Obstetrics & Gynecology ✕
32 devices
Cleared
May 03, 2012
LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF...
Obstetrics & Gynecology
287d
Cleared
Jan 14, 2011
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
Obstetrics & Gynecology
476d
Cleared
Jun 03, 2010
GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
Obstetrics & Gynecology
276d
Cleared
Apr 05, 2010
LIFEGLOBAL PROTEIN SUPPLEMENT
Obstetrics & Gynecology
227d
Cleared
Apr 24, 2009
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
Obstetrics & Gynecology
149d
Cleared
Aug 13, 2008
SUNIVF DISHES
Obstetrics & Gynecology
182d
Cleared
Jul 03, 2007
LG SPERM FREEZING
Obstetrics & Gynecology
112d
Cleared
May 19, 2006
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
Obstetrics & Gynecology
150d
Cleared
May 09, 2006
MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL
Obstetrics & Gynecology
140d
Cleared
Jun 25, 2004
MEDIA CULTURE SYSTEM
Obstetrics & Gynecology
116d
Cleared
Nov 26, 2002
ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)
Obstetrics & Gynecology
75d
Cleared
Aug 30, 2002
PVP (POLYVINYLPYRROLIDONE)
Obstetrics & Gynecology
25d