BEUDAMED
    151 results · 36ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Transcatheter Septal Occluder (Atrial)

    FDA Pre-Market Approval
    FDA Class 3 ·Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack

    Transcatheter Septal Occluder (Atrial)

    FDA Pre-Market Approval
    FDA Class 3 ·Occlutech® ASD Occluder and Occlutech® Pistol Pusher

    Transcatheter Septal Occluder (Atrial)

    FDA Pre-Market Approval
    FDA Class 3 ·Occlutech® ASD Occluder and Occlutech® Pistol Pusher

    Transcatheter Septal Occluder (Atrial)

    FDA classification
    FDA Class 3 ·Transcatheter Septal Occluder (Atrial)

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·CONNECTOR-M1

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPECTRA SYSTEM

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OG(R) CARDIAC PACING SYSTEM

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPECTRA SYSTEM

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Oncomine Dx Target Test

    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)

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, CP, and CP with SmartAssist

    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

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA 2.5 System

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·PyloPlus® UBT System

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella CP Ventricular Support System

    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)