BEUDAMED
    160 results · 38ms · Sources: EU EUDAMED, US FDA
    Filters FDA Pre Market Approval ×

    Analyzer, Medical Image

    FDA Pre-Market Approval
    FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·Oxford Partial Knee System

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·The Oxford Partial Knee System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Endurity, Assurity, Endurity Core, Zenus, Zenex

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01

    Tester, Pacemaker Electrode Function

    FDA Pre-Market Approval
    FDA Class 2 ·ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·GEMNOS(TM)04A CARDIAC PACEMAKER & SWM 600/C00U02

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Multiple Application Utility (MAU) and Data Management System (DM) LATITUDE Programming System )LPS)

    Analyzer, Medical Image

    FDA Pre-Market Approval
    FDA Class 2 ·IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATORS, SPF-PLUS-MINI SPINAL FUSION STIMULATORS

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·MCGHAN SALINE-FILLED BREAST IMPLANTS

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·Mentor Saline-Filled and SPECTRUM® Breast Implants

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·SALINE-FILLED BREAST IMPLANTS

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES