2,357 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA 2.5 SYSTEM
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP Flex with SmartAssist
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella CP with SmartAssist
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Automated Impella Controller
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella CP with SmartAssist
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
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, Impella 5.5 with SmartAssist and Impella LD
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, Impella 5.5 with SmartAssist and Impella LD
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·BOND Oracle HER2 IHC System
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella2.5, ImpellaCP, Impella CP with SmartAssist
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·BOND ORACLE HER2 IHC SYSTEM
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·ANGIOLINK VASCULAR CLOSURE SYSTEM
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella CP with SmartAssist
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 5.5 with SmartAssist
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Automated Impella Controller