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

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    Aerin Medical Stylus

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

    TSRH SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·SOFAMOR DANEK MANUFACTURING·Product code KWQ·January 5, 2000

    APEX KNEE MODULAR TIBIA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C.R. BARD

    FDA Adverse Event
    Injury ·BARD UROLOGICAL DIVISION·Product code KOD·February 9, 1995

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC., SAN ANGELO·Product code GAM·May 5, 2000

    INTRA-AORTIC BALLOON PUMP

    FDA Adverse Event
    Malfunction ·ST. JUDE CARDIAC ASSIST DIVISION·Product code DSP·March 7, 1995

    RESERVOIR 1.8ML MMT-326A

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 10, 2014

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 3, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 14, 2011

    11.0MM CANNULATED CUTTER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWJ·November 27, 2017

    ALPHA I INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·MENTOR UROLOGY, INC.·Product code FHW·October 17, 1997

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;

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