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

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    PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROXIMATE ILS CIRCULAR STAPLES

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006

    COOK WIRE GUIDES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROXIMATE ILS CIRCULAR STAPLERS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006

    CADD LEGACY PLUS PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·January 20, 2025

    CADD LEGACY PLUS PUMP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·September 9, 2022

    ULTRASONIC IMAGING CATHETER - CORONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·February 28, 2013

    COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code CAC·February 4, 2011

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 6, 2014

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024