BEUDAMED
    22 results · 31ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO LTV 1000 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074036687·BONE SCREW 7040540 ILIAC 5.5X40 TI

    Resectoscopy sheath

    FDA UDI
    SOPRO-COMEG GmbH·04059082031415·

    Resectoscopy sheath

    FDA UDI
    SOPRO-COMEG GmbH·04059082031750·

    POLYESTER NONABSORBABLE SURGICAL SUTURES, USP

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

    REGENECARE WOUND GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 19, 2025

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 18, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 27, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 9, 2008

    PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    THERAPY ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·IRVINE BIOMEDICAL, INC.·Product code LPB·October 17, 2008