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

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    AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE

    FDA 510(k)
    FDA Unclassified ·Unknown

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00887517658357·Universal Distractor, Multi-Level

    ONE Super Studs

    FDA UDI
    GLOBAL PROTECTION CORP.·00726893112179·12 Lubricated Male Latex Condoms

    Baby Gorilla/Gorilla Plating System

    FDA UDI
    Paragon 28, Inc.·00889795034991·MTP Spin Guard Female Reamer Protector Sleeve, ...

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD220881117020·8 3/4" Malis Bayonet Bipolar Forceps with Irrig...

    K2M Fenestrated Tap System

    FDA UDI
    VB Spine LLC·10888857530058·Tap, Fenestrated Size Ø4.5

    MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 14, 2013

    ARTICULEZE M HEAD 36MM +12

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·September 23, 2014

    CSF-PERITONEAL CATHETER, STD, OPEN END W/ WALL SLITS, 90CM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·May 25, 2011

    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

    FDA Enforcement
    Class II ·Terminated·Monteris Medical Corp·November 26, 2014

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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