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

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    SPY Portable Handheld Imaging (SPY-PHI) System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BSSO-IN PLACE PLT BENDER SHORT

    FDA UDI
    W.H. Holden, Inc.·D92820073710·

    CAT ACTIVE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    COAXIAL DILATOR SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUVON TENS & EMS DEVICE

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

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PRESTIGE CERVICAL DISC SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code MJO·October 24, 2014

    TOTAL ASR ACET IMP SIZE 56

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013

    4F M-I STIFFEN 40CM NT-SS (610366)

    FDA Adverse Event
    Malfunction ·GALT MEDICAL CORP.·Product code DQX·January 10, 2012

    AUVON TENS UNIT

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

    ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MNH·April 10, 2019

    ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MNH·April 10, 2019

    ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MNH·April 10, 2019

    ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MNH·April 10, 2019

    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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025