BEUDAMED
    23 results · 29ms · Sources: EU EUDAMED, US FDA

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    VENX REVOLUTION

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169601277·SPACER 2110355 OLIF25 20MM 0 DEG 12X55

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1103500·Tray, Base, 3.5", Arcamed

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 26, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·March 2, 2015

    IMPLANT, FIXATION DEVICE CONDYLAR PLATE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JDP·February 23, 2017

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197382007·Standard Tissue Forceps 1x2 te...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197257046·Babcock Intestinal Tissue Forceps 35.5cm...

    REVERSE MEDICAL REFLEX GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUGEASE VASCULAR AUGMENTATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUATTRODE LEAD WIDE SPACED, 60 CM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·July 17, 2023

    IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JDP·June 1, 2015

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 21, 2011

    UNKNOWN MICROCATHETER

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017

    4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017