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

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    SBI STAFIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PALCERAM 53

    FDA 510(k)
    FDA Class 2 ·Dental

    NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code MEH·July 20, 2022

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 27, 2011

    NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·July 9, 2024

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 22, 2013

    DEPUY ASR XL FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·July 2, 2008

    NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 11, 2024

    NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 28, 2024

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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