BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    CAMERA, CLEON 720 LARGE FIELD GAMMA

    FDA 510(k)
    FDA Class 1 ·Radiology

    Coblation

    FDA UDI
    Smith & Nephew, Inc.·00817470001419·PERC DC (OLD)

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196358·AK3 PS-C Insert Trials - Size 1-5 Pan

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690195054·AK3 PS-C Insert Trials - Size 1-5 Pan Insert

    TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector

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

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 5, 2014

    MAXIMO II VR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·October 15, 2012

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·Product code LZG·August 2, 2010

    HF-RESECTION ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

    TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 25, 2023

    HF-RESECTION ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024