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1,032 catalysts · 1,000 device adverse event · 21 approval · 6 device 510k · 3 device pma · 2 grant
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1,032 catalysts · 1,000 device adverse event · 21 approval · 6 device 510k · 3 device pma · 2 grant
Adverse Event Without Identified Device or Use Problem
Leak/Splash
Leak/Splash
Leak/Splash
Patient Device Interaction Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Patient Device Interaction Problem
Patient Device Interaction Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Device Dislodged or Dislocated
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Incorrect Interpretation of Signal
Patient Device Interaction Problem
Calcified; Gradient Increase
Material Fragmentation
Failure to Seal
Adverse Event Without Identified Device or Use Problem
Pumping Stopped
Break; Material Rupture
Device Alarm System; Premature Discharge of Battery
Failure to Capture; High Capture Threshold
Adverse Event Without Identified Device or Use Problem
Gradient Increase; Thickening of Material
Malposition of Device; Patient Device Interaction Problem
Patient Device Interaction Problem
Patient Device Interaction Problem
Material Fragmentation
Adverse Event Without Identified Device or Use Problem
Migration
Insufficient Information
Impedance Problem
Device Dislodged or Dislocated
Naturally Worn
Failure to Osseointegrate
Osseointegration Problem
Structural Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem