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

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    S-BONE HIP TOOL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776289744·Weitlaner Retractor

    TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    G2 FILTER SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 21, 2007

    NEEDLE FILTER 19X1-1/2 TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·March 6, 2024

    G2 FILTER SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·May 15, 2007

    RECOVERY G2 FILTER SYSTEM - JUGULAR DELIVERY KIT

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 23, 2010

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code DTB·April 11, 2013

    PULSE GEN MODEL 104

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·April 11, 2011

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC IRELAND, LTD.·Product code FGE·May 22, 2008

    G2 FILTER SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·September 21, 2007

    HAHN TAPERED IMPLANT 4.3 X 8 MM

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 15, 2020

    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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; 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