BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Dalbo®-Z

    FDA UDI
    Cendres+Métaux SA·07640166513988·Dalbo®-Z Female part O

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0155070·Trial, Drill Guide, 15 x 12, 7mm, Tapered

    MICROPERFORATION INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    PLUS PIVOT LINK UNIVERSAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 4, 2025

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·April 10, 2013

    ULTRACISION** HARMONIC SCALPEL** HAND PIECE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 2, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·April 4, 2011

    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