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12,251 catalysts · 3,603 8k filing · 2,283 grant · 1,771 approval · 1,164 device 510k · 1,000 device adverse event · 848 device pma
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12,251 catalysts · 3,603 8k filing · 2,283 grant · 1,771 approval · 1,164 device 510k · 1,000 device adverse event · 848 device pma
Inappropriate/Inadequate Shock/Stimulation; Migration
Inappropriate/Inadequate Shock/Stimulation; Migration
Loosening of Implant Not Related to Bone-Ingrowth
Adverse Event Without Identified Device or Use Problem
Wireless Communication Problem
Fracture
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
Obstruction of Flow
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Failure to Advance
Adverse Event Without Identified Device or Use Problem
Electrical /Electronic Property Problem; Under-Sensing
Leak/Splash
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