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

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    AcuityPDR

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613153151319·PLATE BENDING PLIERS

    MAYO SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896094055·MAYO SCISSORS STRAIGHT BEVELED BLADE POWER CUT ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694047890·Depth Gauge, ICON

    CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM

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

    DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE

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

    DEEP BRAIN STIMULATOR LEAD

    FDA Adverse Event
    Death ·MEDTRONIC NEUROMODULATION·Product code MHY·February 15, 2008

    AUVON TENS & EMS DEVICE

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    CORAIL AMT COLLAR SIZE 11

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS-3003895575·Product code KWA·October 24, 2014

    MAGNETOM ESPREE

    FDA Adverse Event
    Malfunction ·SIEMENS AG·Product code LNH·August 3, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    AUVON TENS UNIT

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024

    UNKNOWN HIP FEMORAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·September 13, 2019

    UNKNOWN HIP ACETABULAR LINERS

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 13, 2019

    UNKNOWN HIP ACETABULAR LINERS

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LZO·September 13, 2019

    VIDAS® BRAHAMS PROCALCITONIN

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code PRI·November 8, 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

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021