BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    HAND-CARRIED ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810141161·Diamond Polishing Paste

    CoverLoc™ Volar Plate

    FDA UDI
    TORNIER, INC.·00846832001408·FULLY THREADED SCREW

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101160·Distractor, Smooth Paddle, Lordotic, 16mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101160·Distractor, Smooth Paddle, 16mm

    Orbitum Staple System

    FDA UDI
    CPM Medical Consultants, LLC·B565FO20141161·1.1 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive

    PLANMED SOPHIE, PLANMED SOPHIE CLASSIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 28, 2014

    ARCHITECT IPTH

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code CEW·January 24, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    ISOFLEX S

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    ASCENSION CMC SADDLE

    FDA Adverse Event
    Other ·ASCENSION ORTHOPEDICS, INC.·Product code KYJ·March 14, 2008

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code OUT·February 17, 2015

    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

    FDA Enforcement
    Class III ·Terminated·DeVilbiss Healthcare LLC·July 9, 2014

    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