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10,895 catalysts · 3,603 8k filing · 2,256 grant · 1,191 approval · 1,000 device adverse event · 896 device 510k · 642 device pma
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10,895 catalysts · 3,603 8k filing · 2,256 grant · 1,191 approval · 1,000 device adverse event · 896 device 510k · 642 device pma
Off-Label Use; Material Puncture/Hole
Device Appears to Trigger Rejection
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Restricted Flow rate; Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Inflation Problem
Appropriate Term/Code Not Available
Device Appears to Trigger Rejection
Insufficient Information
Migration; Failure to Seal
Migration
Charging Problem
Fluid/Blood Leak; Mechanical Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Premature Discharge of Battery
Unexpected Therapeutic Results
Nonstandard Device
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Charging 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
Positioning Failure
Adverse Event Without Identified Device or Use Problem
Positioning Failure
Firing Problem
Device Appears to Trigger Rejection
Adverse Event Without Identified Device or Use Problem
Failure to Osseointegrate
Adverse Event Without Identified Device or Use Problem
Unintended Collision; Energy Output Problem
Device Stenosis
Key or Button Unresponsive/not Working
Insufficient Information
Positioning Failure
Use of Device Problem
Priming Problem
Adverse Event Without Identified Device or Use Problem
Use of Device Problem
Adverse Event Without Identified Device or Use Problem
Insufficient Information
Adverse Event Without Identified Device or Use Problem
Loose or Intermittent Connection
Migration