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TPLC
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show TPLC since
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Device
bougie, esophageal, and gastrointestinal, gastro-urology
Product Code
FAT
Regulation Number
876.5365
Device Class
2
Premarket Reviews
Manufacturer
Decision
TELEFLEX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
3
3
2019
1
1
2020
2
2
2021
2
2
2023
1
1
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Use of Device Problem
2
2
Detachment of Device or Device Component
2
2
Device Markings/Labelling Problem
2
2
Device Sensing Problem
1
1
Device Dislodged or Dislocated
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Burst Container or Vessel
1
1
Device Expiration Issue
1
1
Leak/Splash
1
1
Delivered as Unsterile Product
1
1
Material Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
3
3
No Clinical Signs, Symptoms or Conditions
3
3
No Information
1
1
Nausea
1
1
Pain
1
1
Perforation
1
1
Vomiting
1
1
No Consequences Or Impact To Patient
1
1
Chemical Exposure
1
1
Foreign Body In Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Endoscopy
II
Feb-01-2011
2
Stryker Endoscopy
II
Dec-28-2010
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