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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
  SUBSTANTIALLY EQUIVALENT 1
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
  1.  K151367  Sydney IVF Hyaluronidase
  2.  K152782  SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT ...
  3.  K153290  Sydney IVF Follicle Flush Buffer, Sydney IVF Ferti ...
  4.  K153478   Sydney IVF Gamete Buffer
  5.  K160814  Sydney IVF Sperm Cryopreservation Buffer
  6.  K170257  Sydney IVF Culture Oil
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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