BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    SPI DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    Resusa-Tee T-Piece Resuscitator

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043515020·

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776313968·Roux Retractor, large

    ENDO LINEAR CUTTERS-ECHELON 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006

    Optimotion Blue CR HCCR Total Knee System

    FDA UDI
    OPTIMOTION IMPLANTS LLC·B6961014P0515020·CR Tibial Insert, UHMWPE + Vitamin E, Size 5, ...

    CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·Product code FOZ·September 10, 2021

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWP·April 10, 2013

    UNKNOWN ZIMMER HIP

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

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT·Product code LWS·May 12, 2008

    EPIDURAL CATHETERIZATION KIT

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAZ·July 12, 2016

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021

    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