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

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·VNS Therapy System

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA Pre-Market Approval
    FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR

    Automated Breast Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE FAMILY OF ICDS

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·EPIC HF/ATLAS + HF FAMILY OF CRT-DS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·PROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT IMX FREE PSA

    Temporary Non-Roller Type Left Heart Support Blood Pump

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

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·SENOCLAIRE

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense