BEUDAMED
    1,303 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·POLARx™ Short Tip (ST) Cryoablation Balloon Catheter, POLARx™ Long Tip (LT) Cryoablation Balloon Catheter, POLARx™ FIT S

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ZOOM LATTITUDE Programmer System Accessory Kit, Adapter Power RF COmmunicator, Accessory Kit Lead Cap, Accessory Wand T

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·Alinity i Anti-HBc Reagent Kit (2x 100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests)

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·AEGEA Vapor System, Aegea Vapor Probe Procedure Kit, Aegea Vapor Generator and Aegea Vapor Generator Accessory Kit

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ENTOVIS, EVIA, ESTELLA, EFFECTA, ECURO, DEXTRUS, SETROX, SELOX, TILDA, P-KIT, SAFIO, SLX, CARDIOMESSENGER LLT KIT, ICS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE/BRILLIANT S+VDD LEADS/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT/THERA-I/VITATRON LEGACY/LEGACY II/VISA

    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

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·PRODIGY IPG/LEADS WRENCH KIT/LEADS SERVICE KIT/VITATRON BRILLIANT S+/CAPSURE VDD LEADS/CONNECTOR PORT PIN-PLUG

    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

    FDA Pre-Market Approval
    FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·HV Splitter/Adaptor kit, Sprint Quattro Lead

    System, Test, Tumor Marker, For Detection Of Bladder Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT Total PSA Reagent/Calibrator/Control Kit

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·HV Splitter/Adaptor kit, Sprint Quattro Lead

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·HV Splitter/Adapter kit, Sprint Quattro Lead

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·QIAGEN therascreen® KRAS RGQ PCR Kit

    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

    FDA Pre-Market Approval
    FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit