592 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5 and Impella CP Ventricular Support System
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain StarFix Lead
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN LEAD
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain StarFix Lead
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain Ability MRI / Plus / Straight SureScan Leads; Attain Performa MRI / Straight / S MRI SureScan Leads
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 5.0 System
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ACUITY STEERABLE LEAD SYSTEM
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus UBT System
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·CONSULTA CRT-P, SYNCRA CRT-P
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN STARFIX MODEL 4195 LEAD
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN ABILITY LEAD
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN ABILITY LEAD DRUG COMBINATION
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA)
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD; ATTAIN ABILITY PLUS MRI SURESCAN LEAD MODEL 4296; ATTAIN ABILITY STRAIGHT MRI
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN BIPOLAR OTW LEAD
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain Ability Lead
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain Ability Lead
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·CONSULTA & SYNCRA CRT-P