BEUDAMED
    307 results · 23ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 2 ×

    BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK

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

    PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Omnipod DASH Insulin Management System with interoperable technology

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HepaShield Bacterial Viral Breathing System Filter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ThermoShield HME Filter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SINGLE USE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Omnipod Insulin Management System, Omnipod DASH Insulin Management System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Omnipod Insulin Management System, Omnipod DASH Insulin Management System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL

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

    21.3” 5MP Color LCD Display UMD5-21B01

    FDA 510(k)
    FDA Class 2 ·Radiology

    21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)

    FDA 510(k)
    FDA Class 2 ·Radiology

    DASH® SARS-CoV-2 & Flu A/B Test

    FDA 510(k)
    FDA Class 2 ·Microbiology