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TPLC
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show TPLC since
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Device
accessory, assisted reproduction
Product Code
MQG
Regulation Number
884.6120
Device Class
2
Premarket Reviews
Manufacturer
Decision
AT MEDICAL UAB
SUBSTANTIALLY EQUIVALENT
2
GENEA BIOMEDX PTY LTD
SUBSTANTIALLY EQUIVALENT
3
1. K171736
Geri Embryo Incubator and Geri Dish
2. K180188
Geri Embryo Incubator with Geri Connect and Geri A
...
3. K180304
Geri Embryo Incubator and Geri Dish
ORIGIO, INC
SUBSTANTIALLY EQUIVALENT
1
PLANER PLC
SUBSTANTIALLY EQUIVALENT
1
RESEARCH INSTRUMENTS LIMITED
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD
SUBSTANTIALLY EQUIVALENT
1
UNISENSE FERTILITECH A/S
SUBSTANTIALLY EQUIVALENT
4
VITROLIFE A/S
SUBSTANTIALLY EQUIVALENT
1
WILLIAM A. COOK AUSTRALIA PTY LTD
SUBSTANTIALLY EQUIVALENT
1
WUHAN HUCHUANG UNION TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
1
1
2019
2
2
2020
3
3
2023
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inappropriate/Inadequate Shock/Stimulation
2
2
Mechanical Problem
2
2
Off-Label Use
1
1
Sparking
1
1
Device Operates Differently Than Expected
1
1
Device Sensing Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Unintended Electrical Shock
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3
3
Electric Shock
2
2
No Known Impact Or Consequence To Patient
1
1
No Code Available
1
1
Hemorrhage/Bleeding
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Apr-19-2018
2
Cook Inc.
II
Apr-13-2018
3
Cook Medical Llc
II
Jan-12-2024
4
Cook Medical Llc
II
Jan-08-2021
5
CooperSurgical, Inc.
II
Sep-28-2022
6
CooperSurgical, Inc.
III
Oct-02-2019
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