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8,305 catalysts · 3,603 8k filing · 1,378 grant · 1,000 device adverse event · 644 approval · 583 earnings · 492 device 510k
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8,305 catalysts · 3,603 8k filing · 1,378 grant · 1,000 device adverse event · 644 approval · 583 earnings · 492 device 510k
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: APPR
Insufficient Information
Appropriate Term/Code Not Available
Failure to Osseointegrate
Leak/Splash; Loose or Intermittent Connection
Patient-Device Incompatibility
Malposition of Device
Insufficient Information
Failure to Osseointegrate
Insufficient Information
Loss of Osseointegration
Insufficient Information
Failure to Osseointegrate; Migration
Failure to Osseointegrate
Collapse; Fluid/Blood Leak
Insufficient Information
Incorrect, Inadequate or Imprecise Result or Readings
Patient Device Interaction Problem
Low Readings
Insufficient Information
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Failure to Osseointegrate
Patient Device Interaction Problem
Patient Device Interaction Problem
Adverse Event Without Identified Device or Use Problem
High Readings
Adverse Event Without Identified Device or Use Problem
Charging Problem
Material Rupture
Low Readings
Osseointegration Problem
Loss of Osseointegration
Material Rupture
Adverse Event Without Identified Device or Use Problem
Migration
Adverse Event Without Identified Device or Use Problem
Improper or Incorrect Procedure or Method
Device Appears to Trigger Rejection
Positioning Failure; Insufficient Information
Loss of Osseointegration
Insufficient Information
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Premature Discharge of Battery
Loss of Osseointegration
Unable to Obtain Readings; Device Displays Incorrect Message
Appropriate Term/Code Not Available
Appropriate Term/Code Not Available