BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    SYMPHONY™ OCT System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613103224·McCulloch Retractor, 4 Black Teeth, 90mm Long B...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613105556·McCulloch Retractor, 6 Black Teeth, 120mm Long ...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613105525·McCulloch Retractor, 6 Black Teeth, 90mm Long B...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613105532·McCulloch Retractor, 6 Black Teeth, 100mm Long ...

    PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601

    FDA 510(k)
    FDA Class 2 ·Radiology

    AC WOUND TREATMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613103262·McCulloch Retractor, 4 Black Teeth, 120mm Long ...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613103231·McCulloch Retractor, 4 Black Teeth, 100mm Long ...

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023

    SECURA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·July 28, 2011

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code HDD·June 21, 2013

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·September 22, 2008

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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