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

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    MINIQUANT D-DIMER, MODEL 1447

    FDA 510(k)
    FDA Class 2 ·Hematology

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496002642·NAOMI 140, SIZE XL, NERO, GRADUATED COMPRESSION...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450198674·

    TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code KDC·June 29, 1994

    MULTIFEED STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code GAG·June 29, 1994

    REDUCER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code KDC·June 29, 1994

    STABILITY THREAD

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code KDC·June 29, 1994

    TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INSIGHT IMAGE GUIDED SURGICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JIX·December 15, 2011

    FS DISPOSABLE INTERFACE

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code GEX·October 9, 2025

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·March 13, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 9, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 8, 2008

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 8, 2024

    Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.

    FDA Enforcement
    Class III ·Terminated·Beckman Coulter Inc.·October 31, 2012

    SENSAR IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·September 27, 2024

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024