BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    AURA-PSG

    FDA 510(k)
    FDA Class 2 ·Neurology

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306810794·Ragnell-Kilner Scissors, Straight, 12cm

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"

    EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ISOBAR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIEMENS : ARTISTE MV

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·July 30, 2010

    PLUM XL PLS MIC/MAC

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 8, 2013

    TENDRIL SDX

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 5, 2011

    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

    FDA Enforcement
    Class II ·Terminated·Ondamed Inc·May 16, 2018

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024