BEUDAMED
    16 results · 34ms · Sources: EU EUDAMED, US FDA

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    GS III SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450267448·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112080·Tap, 7.50mm

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0112080·Rasp, 8 and 10mm

    icotec Pedicle System 6.0, Rod, Ti, Curved, Ø 6.0 r120 x 080 mm

    FDA UDI
    icotec AG·07640164848709·icotec Pedicle System 6.0, Rod, Ti, Curved, Ø ...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112080·Tap, Cannulated, 6.5 mm

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    ESPIRT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIOVER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PANORAMA CENTRAL STATION W/TELEPACK

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    GO BED 2

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 20, 2011

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    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