BEUDAMED
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    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Eterna SCS System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL 9974

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL9974

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 SERIES INFLATABLE PENILE PROSTHESIS (IPP) WITH AND WITHOUT INHIBIZONE TREATMENT

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

    Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Samsung ECG Monitor App with Irregular Heart Rhythm Notification

    FDA UDI
    Samsung Electronics Co., Ltd.·08806094948240·The Samsung ECG Monitor Application with Irregu...

    Canary OR Base Station / OR PC App / OR Registration

    FDA UDI
    Canary Medical USA LLC·00860003118313·The OR Base Station subsystem is intended to se...

    reSET® Introductory Access Limited Version (Mobile App, Android)

    FDA UDI
    PEAR THERAPEUTICS, INC.·10851580008156·reSET® Mobile Application running on Android. r...

    Chembio DPP HIV 1/2 Rapid Test Control Pack

    FDA UDI
    Chembio Diagnostic Systems Inc.·00607158000045·The Chembio HIV Reactive/Nonreactive Controls a...

    Samsung ECG Monitor App with Irregular Heart Rhythm Notification

    FDA UDI
    Samsung Electronics Co., Ltd.·08806094948233·The Samsung ECG Monitor Application with Irregu...

    reSET® Introductory Access Limited Version (Mobile App, iOS)

    FDA UDI
    PEAR THERAPEUTICS, INC.·10851580008149·reSET® Mobile Application running on iOS. reSET...

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700, AMS AMBICOR, AMS 700 WITH MS PUMP INFLATABLE PENILE PROSTHESIS (IPP)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974

    SAS SALMONELLA H U ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QUICKVUE IN-LINE ONE-STEP STREP A TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    STREP B OIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CARDS(TM) STREP A CATALOG NO. CR-7545

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SAS SALMONELLA O FACTOR 20 ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology