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

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    Eviva Stereotactic Guided Breast Biopsy System

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

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776187613·PROBE WEYE - STERLING

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776375645·PROBE W/EYE 5-1/2 STERLING

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780379706·Integra® Jarit® Probe With Eye, 5-1/2", Silver

    VERSANT DYNASTY

    FDA UDI
    FGX INTERNATIONAL INC.·00193033308356·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694094351·Neuro Mastoid Plate, Large

    Cannula, Suction, acc. Braun-Ralph 31.5cm Ø7mm tip unscrewable

    FDA UDI
    Geister Medizintechnik GmbH·04057034039618·Cannula, Suction, acc. Braun-Ralph 31.5cm...

    Cannula, Suction, acc. Braun-Ralph spare part suction tip

    FDA UDI
    Geister Medizintechnik GmbH·04057034039687·Cannula, Suction, acc. Braun-Ralph spare ...

    HAIRMAX LASERCOMB

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SUDOSCAN

    FDA 510(k)
    FDA Class 2 ·Neurology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 15, 2014

    SMALL PERIPHERAL CUTTING BALLOON?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    CARTO 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 14, 2023

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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

    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