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

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    MERETEK UBT_LITE BREATH TEST FOR H. PYLORI

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Quadrato

    FDA UDI
    Nuvasive, Inc.·00887517409799·Quadrato Trial Sizer, 16mm

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034005898·ISOLA SPINE SYSTEM OPEN HOOK,RAISED SUPRALAMINA...

    Alpine

    FDA UDI
    Ortho Development Corporation·00822409018888·Alpine Centralizer 16 mm

    CARDIOSAVE HYBRID W/ E/F PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·December 20, 2024

    e-vive II NMES System

    FDA UDI
    Motive Health, Inc.·00854691008896·e-vive II NMES System; S/M, Left

    SPACELABS HEALTHCARE

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522111730·CABLE,PX,LCF,6RECEPTACLE,AHA,WO/LEADWIRES,ROHS

    Spacelabs Healthcare

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522125270·CABLE,PX,LCF,6RECEPTACLE,AHA,WO/LEADWIRES,ROHS

    VASCO TIP BI 9/58

    FDA Adverse Event
    Injury ·VASCOR MEDICAL CORP.·Product code DTB·April 12, 2000

    BARCOMED 5MP2

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BIOMET TIB BLOCK 6MM 79

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 12, 2013

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code MUZ·February 18, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 11, 2014

    LEEP PRECISION GENERATOR

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·November 21, 2023

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·December 5, 2016

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016