592 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·On- X Prosthetic Heart Valve, Ascending Aortic Prothesis
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·On-X Prosthetic Heart Valve and Ascending Aortic Prothesis
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, MODEL ONXAC
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·PRODISC TM-C TOTAL DISC REPLACEMENT
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK 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
·CONSULTA CRT-P AND SYNCRA CRT-P
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·INSYNC III CRT-P/ATTAIN OTW LEAD/BIPOLAR OTW/LV LEADS
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain Ability Leads, Attain Performa Leads, Attains Stability Quad MRI Lead
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, CP, and CP with SmartAssist
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN ABILITY LEAD
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN/INSYNC/INSYNC III
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEAD, ATTAIN PERFORMA LEAD
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain Ability Lead; Attain Performa Lead
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain Stability Quad MRI Surescan
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·INSYNC III (IPG)
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA 2.5 System
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·SYNCRA CRT-P, CONSULTA CRT-P