BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    PLT-4 SIZE-CHECK

    FDA 510(k)
    FDA Class 2 ·Hematology

    BD PLASTIPAK LUER-LOK 30 ML SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 12, 2019

    BD INSYTE ¿ IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FOZ·September 6, 2018

    ELECSYS FERRITIN CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1

    FDA 510(k)
    FDA Class 2 ·Neurology

    VASC BAND

    FDA Adverse Event
    Injury ·LEPU MEDICAL TECHNOLOGY CO., LTD.·Product code DXC·May 9, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 5, 2007

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·October 23, 2012

    NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

    FDA Enforcement
    Class II ·Terminated·Navilyst Medical, Inc·March 4, 2015

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017