BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    HEMOCUE WBC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    VASCUPUNCTURE PICC GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BODY FAT ANALYZER, MODEL HBF-306

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 5, 2022

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·April 22, 2013

    PFC SIGMA/OV DOME PAT 3 PEG,32

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 15, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Death ·RICE CREEK MANUFACTURING·Product code LKK·July 9, 2008

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 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