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

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    RESPIRONICS PERFORMAX SE TOTAL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·October 17, 2016

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 17, 2026

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·July 2, 2014

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 27, 2017

    PULSE GEN MODEL 105

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·May 3, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 19, 2014

    QUATTRODE LEAD, 3/4MM, 60 CM

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2011

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·January 18, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024