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

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    TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Premier H-FILES

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6919053430·FILES HEDSTROM PKG 6 25MM 35

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809842166·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE LARGE FU...

    ACE BIO WIN TIBIAL NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UF BRACHYTHERAPY STAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARCOS 3.5MM HEX DRIVE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·October 6, 2023

    2.4MM TI COMPRESSION TENSION BAND PLATE 6 HOLES/36MM

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code JEY·April 11, 2013

    LIFEPAK CR® PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·March 17, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·May 27, 2008

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    DYB INTRODUCER, CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·November 12, 2025

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·September 15, 2020

    MDLR CNLTD TRIDRV DRVR

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code LXH·August 29, 2023

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·February 7, 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

    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