BEUDAMED
    24 results · 24ms · Sources: EU EUDAMED, US FDA

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    PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE

    FDA 510(k)
    FDA Class 2 ·Hematology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890105991·Zirlux Snappy Abut Analog 5.5

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036008420·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450129142·

    MAGNIVISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033179352·

    ACTI-FLEX IV ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VITALOGRAPH BASE STATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 28, 2024

    GALAXY G3 MINI 1MM X 1CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·September 9, 2010

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·July 15, 2022

    ACCESS

    FDA Adverse Event
    BAXTER HEALTHCARE - MALTA·Product code FPA·March 19, 2013

    LEAD MODEL 304

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·March 1, 2011

    RIATA PASSIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    BLUNT TIP SCREW, 4X46MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 7, 2020

    PROXIMAL HUMERUS, RIGHT, 11X160MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 6, 2020

    BLUNT TIP SCREW, 4X42MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 6, 2020

    BLUNT TIP SCREW, 4X40MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 8, 2020

    BLUNT TIP SCREW 4X48MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 8, 2020

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·September 6, 2023