BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    LIFEPAK 15 monitor/defibrillator

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741424300·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674142430060·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1424300·14mm H x 24mm W x 30mm L x 0 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X14243080·14mm H x 24mm W x 30mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X142430120·14mm H x 24mm W x 30mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L142430120·14mm H x 24mm W x 30mm L XLIF Trial 12 degree L...

    Chic

    FDA UDI
    Gc Orthodontics America Inc.·E53514243000101·CHIC ROTH 022/LR3 -11T 7A 2M

    Chic

    FDA UDI
    Gc Orthodontics America Inc.·D78814243000101·CHIC ROTH 022/LR3 -11T 7A 2M

    TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 5, 2014

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 3, 2013

    SCORPIO TS TIB INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·June 21, 2011

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

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