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

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    DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809841930·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE EXTRA LA...

    E-ON

    FDA UDI
    BENCO DENTAL SUPPLY CO.·D74450533630·E-ON UNIV COMP LC .25GM D3 PK15

    CROSSPOINT TRANSACCESS CATHETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    M2A 32MM TAPER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROSTHESIS, HIP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021

    TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSX·February 3, 2017

    HEARTMATE II LVAS

    FDA Adverse Event
    THORATEC CORPORATION·Product code DSQ·April 11, 2013

    AUTOMIX 3+/AS COMPOUNDER (REFURBISHED)

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - LARGO·Product code NEP·April 13, 2011

    TRIATHLON CR X3 TIBIAL INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code HSH·May 28, 2008

    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