BEUDAMED
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    HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·ACE(TM) AND LONG ACE(TM) MODELS

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·UltiPace Pacing Lead, Tendril STS Pacing Lead

    OTELO LL

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRYPTIK2C-plate Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROMEO 2 PAD POSTERIOR AXIAL DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JULIET OL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JULIET LL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Perla Posterior Cervico-Thoracic Fixation system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Romeo posterior osteosynthesis system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JULIET PO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Juliet® Ti

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JULIET® LL Lateral Lumbar Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM