BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111095979·F.O. MILLER AMER STYLE SIZE 3

    QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SURGASSIST FLEXSHAFT 2, MODEL FS2 14

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2025

    PRECISION? MONTAGE? MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 10, 2025

    CONVEEN STANDARD 1500 ML

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FAQ·April 22, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code BRZ·April 27, 2011

    PORO TRI-LOCK FEM 10.0 STD NK

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDG·July 7, 2008

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·October 10, 2018

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018