BEUDAMED
    59 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Fda510k ×

    MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP

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

    ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Caretaker Remote Display App and Caretaker Software Library

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand

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

    InPen System App (MMT-8060 (iOS), MMT-8061 (Android))

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Rooti Rx ECG Event Recorder, Rooti Link APP Software

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.

    FDA 510(k)
    FDA Class 2 ·Dental

    VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Helix Genetic Health Risk App for late-onset Alzheimer’s disease

    FDA 510(k)
    FDA Class 2 ·Immunology

    FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

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

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

    Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App

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

    Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App

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