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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device media, reproductive
Product CodeMQL
Regulation Number 884.6180
Device Class 2


Premarket Reviews
ManufacturerDecision
INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTSMEDIA DENMARK APS
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
DONNEVIE MEDICAL TECHNOLOGY (SHANGHAI) CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM IRVINE SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENEA BIOMEDX PTY LTD
  SUBSTANTIALLY EQUIVALENT 3
GENX INTL., INC.
  SUBSTANTIALLY EQUIVALENT 4
GIMBO MEDICAL TECHNOLOGY SHENZHEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON THORNE INC.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON THORNE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
HAMILTON THORNE, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
IRVINE SCIENTIFIC SALES CO., INC.
  SUBSTANTIALLY EQUIVALENT 6
KITAZATO BIOPHARMA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
KITAZATO CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
LIFEGLOBAL GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 2
NIDACON INTERNATIONAL AB
  SUBSTANTIALLY EQUIVALENT 1
ORIGIO A/S
  SUBSTANTIALLY EQUIVALENT 10
ORIGIO A/S, A COOPERSURGICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VITAVITRO BIO-TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VITAVITRO BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
VITROLIFE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 5
VITROLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITROMED GMBH
  SUBSTANTIALLY EQUIVALENT 4
VITROMED LANGENFELD
  SUBSTANTIALLY EQUIVALENT 1
WILLAM A. COOK AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM A. COOK AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 6
WILLIAM A. COOK AUSTRALIA PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 4
WILLIAN A. COOK AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG HORIZON MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2016 2 2
2023 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 3 3
Insufficient Information 1 1
Break 1 1
Microbial Contamination of Device 1 1
Chemical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Toxicity 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook, Inc. II Mar-28-2012
2 CooperSurgical, Inc. II Feb-14-2024
3 CooperSurgical, Inc. II Apr-06-2023
4 CooperSurgical, Inc. II Jan-31-2023
5 CooperSurgical, Inc. II Jul-20-2022
6 CooperSurgical, Inc. II Oct-13-2020
7 CooperSurgical, Inc. III Sep-20-2016
8 Fujifilm Irvine Scientific, Inc. II Feb-06-2024
9 Fujifilm Irvine Scientific, Inc. II Apr-01-2023
10 Fujifilm Irvine Scientific, Inc. II Nov-17-2021
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