BEUDAMED
    23 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·GEM MODEL 7227 CX/B/D/E

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·Ilivia Neo 7 HF -T QP, Ilivia Neo 7 HF -T, Intica Neo 7 HF -T QP, Intica Neo 7 HF -T, Intica Neo 5 HF -T QP, Intica Neo

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-T

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume™ BPH Catheter System

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume™ BPH Catheter System

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume™ BPH Catheter System

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Pulse Generator, Permanent Implantable

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·BD Onclarity HPV Assay/BD COR System

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·LUMAX FAMILY OF ICDS AND CRT-DS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Rayner C-flex 570C, C-Flex Aspheric 970C and 600C Aspheric Intraocular lenses

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·BD Onclarity HPV Assay

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·COMBI 40+COCHLEAR IMPLANT SYSTEM,C40+S(COMPRESSED)ELECTRODE ARRAY/C40+ GB (SPLIT) ELECTRODE ARRAY

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; MED-EL COMBI 40+ (STANDARD), COMBI 40+S (COMPRESSED), AND COMBI 40+ GB (SPLITS

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·IGOTIS 5 HF-T (DF-4), 7 HF-T (DF-4, LI); IFORIA 7 HF-T (DF4, GB) IIESTO 5 HF-TIESTO 5 HF-T (DF-4)