BEUDAMED
    872 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

    Salivary Estriol Test

    FDA Pre-Market Approval
    FDA Class 3 ·SALEST TM SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·ANIMAS VIBE SYSTEM

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE CARDIOFORM Septal Occluder

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER

    Prosthesis, Posterior Spinal Elements

    FDA Pre-Market Approval
    FDA Class 3 ·TOPS™ System

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense®

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

    FDA Pre-Market Approval
    FDA Class 3 ·VIDAS TPSA ASSAY

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·VISX STAR S2 AND S3 EXCIMER LASER SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·KAMRA INLAY

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense

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

    FDA Pre-Market Approval
    FDA Class 3 ·Sangia Total PSA Test