BEUDAMED
    17 results · 32ms · Sources: EU EUDAMED, US FDA

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    3S Safety Syringe with/without Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741424350·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674142435060·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1424350·14mm H x 24mm W x 35mm L x 0 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L142435120·14mm H x 24mm W x 35mm L XLIF Trial 12 degree L...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X142435120·14mm H x 24mm W x 35mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X14243580·14mm H x 24mm W x 35mm L x 8 degrees XLIF

    BEYONDIMAGE WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    COOPER PROSTHETIC

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    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

    DEPUY ASR XL FEM IMP SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·June 3, 2013

    ULTRACISION * SURG DEV, SHEARS, ENDOSCOPIC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·June 28, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·October 5, 2014

    INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·September 22, 2025

    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