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

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    STERIS CMAX XLT SURGICAL TABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.30cm, without wire

    FDA UDI
    Promepla·03700512967576·

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027247·

    VISUALINE BARBITURATES DIPSTRIP TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DRIP ALERT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PLASTIC LIP AND CHEEK SELF-RETAINING RETRACTOR, SELF RETAINING, CHILD SIZE

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code EIG·January 30, 2018

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code IWJ·November 15, 2007

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020