BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    K2M Patient Specific Rods

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FUKUSHIMA SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896009691·FUKUSHIMA SUCTION TUBE

    FUKUSHIMA SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0991803760·FUKUSHIMA SUCTION TUBE

    BYTE DAY ALIGNERS

    FDA Adverse Event
    Malfunction ·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024

    EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONCOBIONIC SYSTEM

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 23, 2020

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 14, 2023

    NANOKNIFE SYSTEM

    FDA Adverse Event
    Injury ·ANGIODYNAMICS·Product code OAB·June 9, 2015

    HUDSON OXYGEN SUPPLY TUBING

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code CAI·October 15, 2014

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    LIGAMAX-5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 27, 2011

    3.5 FR SINGLE LUMEN URETHANE UMBILICAL VESSEL CATHETER

    FDA Adverse Event
    TYCO HEALTH CARE/KENDALL·Product code FOS·October 24, 2007

    Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022

    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014