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

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    SCB/STERIS OR-LIGHT INTERFACE BOX

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

    Resusa-Tee T-Piece Resuscitator

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043515051·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450139134·

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0155050·Trial, Drill Guide, 15 x 12, 5mm, Tapered

    ONLINE DAT II METHADONE II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TRANSVENOUS LEAD

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    UNKNOWN ZIMMER HIP

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·April 7, 2011

    VIP PLUS

    FDA Adverse Event
    Malfunction ·EDWARD LIFESCIENCES, LLC·Product code DYG·April 28, 2008

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010

    Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-111.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·December 20, 2004

    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

    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