BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    RESTORATION MODULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58210513630·

    JOE LUBE CONDOM

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

    ENDOVASCULAR GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.·Product code DYB·March 29, 2024

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    SCISSUM RT TRI FLANGE SZ26

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 10, 2013

    NDHP 0.2 MICRN HP CL

    FDA Adverse Event
    Injury ·HOSPIRA, LTD·Product code FPA·April 7, 2011

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 9, 2008

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018