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

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    STERIS Patient Warming System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Intraoral Scan Body 4.3

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059075267·

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312K90044610001·Dowel Pin 12 mm

    ACUMED

    FDA UDI
    Acumed LLC·10806378013980·3.5mm x 8.0mm Locking Cortical Screw

    OSTEOTOME-PTERYGOID 10MM

    FDA UDI
    W.H. Holden, Inc.·D9282004460·

    ACUMED

    FDA UDI
    Acumed LLC·10806378013997·3.5mm x 8.0mm Locking Cortical Screw

    CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD PRECISION GLIDE NEEDLE 26G 1/2IN BROWN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·January 14, 2022

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·October 24, 2014

    UNICEL® DXI 800 IMMUNOASSAY SYSTEM (W/ DUAL GANTRY)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    GORE TEX® VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·April 11, 2016

    GORE TEX® VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·April 11, 2016

    PLATE,FIXATION,BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·February 22, 2019

    PLATE,FIXATION,BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·February 22, 2019

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·February 22, 2019

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·February 22, 2019

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014