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

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    Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System

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

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304240728·

    AGXO

    FDA UDI
    Oticon A/S·05707131283788·H100V2, BTE 13 WL 100 STG AGXO

    1.5MM SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036083434·

    NobelProcera®

    FDA UDI
    Nobel Biocare AB·07332747099362·Procera Implant Bridge Ti Abut Level 10unit

    ROMIAPEX MODEL A-15

    FDA 510(k)
    FDA Unclassified ·Unknown

    VISULIZE FACTOR IX ANTIGEN KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103928·T³ Acetabular Hemispherical Shell, No Hole, 54mm

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 46

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2016

    ZEPHYR XL DR.

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    HIP HEAD, 10/12 TAPER, 28MM, +0MM

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWY·June 30, 2011

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 29, 2019

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·September 8, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 23, 2019

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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