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TPLC
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show TPLC since
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Device
colposcope (and colpomicroscope)
Product Code
HEX
Regulation Number
884.1630
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOP MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
COOPER SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ECLERIS USA
SUBSTANTIALLY EQUIVALENT
1
EDAN INSTRUMENTS, INC.
SUBSTANTIALLY EQUIVALENT
1
FORTH PHOTONICS HELLAS SA
SUBSTANTIALLY EQUIVALENT
1
GYNIUS AB
SUBSTANTIALLY EQUIVALENT
1
HADLEIGH HEALTH TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
ILLUMIGYN LTD.
SUBSTANTIALLY EQUIVALENT
1
LUTECH INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
3
MEDGYN PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
MOBILEODT LTD.
SUBSTANTIALLY EQUIVALENT
1
PERIWINKLE TECHNOLOGIES PVT. LTD
SUBSTANTIALLY EQUIVALENT
1
SEILER PRECISION MICROSCOPES
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN GOLDCARE MEDITECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
STI MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
STI MEDICAL SYSTEMS, LLC
SUBSTANTIALLY EQUIVALENT
1
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2019
2
2
2020
1
1
2021
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3
3
Detachment of Device or Device Component
2
2
Defective Component
1
1
Material Fragmentation
1
1
Electrical /Electronic Property Problem
1
1
Malposition of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2
2
Abnormal Vaginal Discharge
1
1
No Known Impact Or Consequence To Patient
1
1
Foreign Body In Patient
1
1
Injury
1
1
Burn(s)
1
1
No Consequences Or Impact To Patient
1
1
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