BEUDAMED
    152 results · 22ms · Sources: EU EUDAMED, US FDA

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    SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Encompass Hip Stem

    FDA UDI
    Ortho Development Corporation·00822409012794·9mm Distal Centralizer

    INTREPED, Intraosseous Fusion Device

    FDA UDI
    Auxano Medical LLC·00850055649101·INTREPED 09 Drill

    LIBERTA RECHARGEABLE IPG

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code MHY·June 7, 2024

    ZEUS-O

    FDA UDI
    SPINAL ELEMENTS·00840606151405·ZEUS®-O 9MM DILATOR

    Merit® Kit

    FDA UDI
    Merit Medical Systems, Inc.·00884450276990·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100090·Tray Insert 2, Cosmolock, Arcamed

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K1100090·Tray Insert

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100090·Tray Insert

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREELITE HUMAN KAPPA AND LAMBDA KITS

    FDA 510(k)
    FDA Class 2 ·Immunology

    PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·August 5, 2019

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·BRIO NEUROSTIMULATION SYSTEM

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·May 28, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 25, 2011

    VENTAK PRIZM

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 3, 2014

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·March 28, 2018

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 15, 2020

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·December 6, 2024