BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO: MINIMESH POLYPROPYLENE MESH

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

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496053361·NIGHT WELLNESS 70, SIZE L, NERO, GRADUATED COMP...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809841954·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE MEDIUM K...

    NA

    FDA UDI
    Conmed Corporation·10845854000366·7 X 20 X 0.25MM MICRO-AIRE SAGITAL BLADE REPLAC...

    RENEW LS-2

    FDA 510(k)
    FDA Class 2 ·Dental

    WIN-2 TANGO ELITE NP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

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

    SMALL ELECTRIC DRIVE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

    BD ANGIOCATH PLUS¿ VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·August 6, 2018

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·April 11, 2013

    5.5MM TOMCAT CUTTER, FORMULA (5BX)

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY PUERTO RICO·Product code HRX·March 16, 2011

    OFFSET ADAPTER 4MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code FJP·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