BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    K082959

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664812412·SpO2 interface cable/Philips-Masimo/2.2M/309+12...

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735463947·One-piece ECG Monitor Cable Philips

    OPTIMUM

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975067807·Optimum® HP Bone Cutter Carbide Bur Long Tapere...

    INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPTIMA MX

    FDA 510(k)
    FDA Class 1 ·Dental

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

    BD¿ SYRINGE WITH BD LUER-LOK¿ TIP

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·August 9, 2018

    BD VACUTAINER BRAND NEEDLES

    FDA Adverse Event
    Malfunction ·Product code FMI·April 29, 2011

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·April 29, 2013

    AFFINITY 4

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·July 23, 2008

    PRESIDIO 10 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    PRESIDIO 18 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012