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TPLC
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Device
microtools, assisted reproduction (pipettes)
Product Code
MQH
Regulation Number
884.6130
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
JIEYING LABORATORY INC.
SUBSTANTIALLY EQUIVALENT
1
LIFEGLOBAL GROUP, LLC
SUBSTANTIALLY EQUIVALENT
1
RESEARCH INSTRUMENTS LIMITED
SUBSTANTIALLY EQUIVALENT
1
RESEARCH INSTRUMENTS LTD.
SUBSTANTIALLY EQUIVALENT
1
SUNLIGHT MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
VITROMED GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2016
2
2
2017
1
1
2019
4
4
2021
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Nonstandard Device
4
4
Insufficient Information
3
3
Microbial Contamination of Device
3
3
Product Quality Problem
2
2
Material Deformation
1
1
Material Rupture
1
1
Device Operates Differently Than Expected
1
1
Crack
1
1
Defective Device
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Contamination
1
1
Material Fragmentation
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
7
7
No Known Impact Or Consequence To Patient
6
6
No Clinical Signs, Symptoms or Conditions
2
2
Death
1
1
Bone Fracture(s)
1
1
No Patient Involvement
1
1
Insufficient Information
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CooperSurgical, Inc.
II
May-17-2019
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