• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device media, reproductive
Regulation Description Reproductive media and supplements.
Product CodeMQL
Regulation Number 884.6180
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 10
FERTI PRO N.V.
  SUBSTANTIALLY EQUIVALENT 2
GENX INTL., INC.
  SUBSTANTIALLY EQUIVALENT 5
HALOZYME THERAPEUTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 34
MEDICULT
  SUBSTANTIALLY EQUIVALENT 26
NONE
  SUBSTANTIALLY EQUIVALENT 15
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
VITROLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 26
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Known Device Problem 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook, Inc. II Mar-28-2012
2 CooperSurgical, Inc. III Sep-20-2016

-
-