BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    INTERPROXIMAL REDUCTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809841886·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE LARGE-LO...

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776351878·Dressing Forcep

    HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACROTHERM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNS·June 8, 2021

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQX·October 16, 2009

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 11, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 3, 2014

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC.·Product code NWX·March 16, 2011

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·May 19, 2021

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

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

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010

    SYNCHRO2-14 SUPPORT STRAIGHT 215CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023

    Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·February 24, 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