BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    ADHESIVE 1

    FDA 510(k)
    FDA Class 2 ·Dental

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902954801·CASE 7050331 CDHL DGNRTV INS TRAY 1

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099839·MD 1ST BI BD KT N/L UNIV 97

    SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 10, 2013

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·May 27, 2008

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·March 19, 2024

    G7 PPS LTD ACET SHELL 58G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·March 18, 2024

    RESPIRONICS DREAMSTATION

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·October 8, 2021

    G7 VIT E NEUTRAL LNR 36MM G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 11, 2024

    TIBIAL NAIL, STANDARD T2 TIBIA Ø12X330 MM

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HSB·April 7, 2025

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014