BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033504·Baltic Denture System BDLoad BDLoad Sw6 PLSEbm...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0315040·Probe, 1.5 inch Ball, Lenke, Straight, Impaction

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm

    MODIFICATION TO: ECAT LSO PET/CT SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    RT-PLUS MODULAR CEMENTED KNEE COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERJECT?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FCG·April 3, 2013

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·March 24, 2011

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·April 23, 2008

    PINNACLE SECTOR II CUP 60MM

    FDA Adverse Event
    Injury ·. DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·May 25, 2018

    Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·December 29, 2003

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013