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

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    STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541

    FDA 510(k)
    FDA Unclassified ·Unknown

    NA

    FDA UDI
    Richard Wolf GmbH·04055207012512·LITHOARM PHILIPS/LONG

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741096181·Catheter Placement Kit

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040093785·Maxima Reamers 25mm

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810003991·REAMERS 25MM

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501457·TeWa 5CB-Type 2515 Speed Pak: coated acupunctu...

    TEWA

    FDA UDI
    asia-med GmbH·04251282508777·TeWa 5CB-Type 2515 Speed Pak: coated acupunctu...

    CAMLOG SCREW IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CORTEK MINI LAPAROSCOPE

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

    LEVEL 1 TRAUMA FAST FLOW SYSTEM

    FDA Adverse Event
    Malfunction ·OAKDALE·Product code BSB·December 18, 2021

    CADD CASSETTE RESERVOIRS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·August 16, 2021

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·July 23, 2021

    PFC*SIGMA/OV/DOME PAT 3PEG,38

    FDA Adverse Event
    Injury ·DEPUY RAYNHAM·Product code JWH·March 12, 2013

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 10, 2011

    PFC KEEL TIB TRAY CEM SZ 5

    FDA Adverse Event
    Injury ·DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 19, 2008

    LEVEL 1 FAST FLOW FLUID WARMER

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code BSB·August 18, 2022

    SINGLE USE LIGATING DEVICE

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code MND·September 4, 2024

    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