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

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    GASTRIC SUCTION AND DRAINAGE CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 21, 2024

    PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    XIA SCREW 6, 5 X 40

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTJ·August 1, 2025

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTJ·January 31, 2024

    OMEGA 21 SYSTEM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code MNH·March 13, 2013

    PINN SECTOR W/GRIPTION 52MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 16, 2011

    COVIDIEN/KENDALL

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·February 21, 2008

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTJ·September 18, 2023

    ExactaMix EVA Container, 250mL, REF: 737, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set

    FDA Recall
    Terminated ·Baxa Corporation·Product code LHI·March 8, 2011

    ExactaMix EVA Container, 1000mL, REF: 739, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set

    FDA Recall
    Terminated ·Baxa Corporation·Product code LHI·March 8, 2011

    ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set

    FDA Recall
    Terminated ·Baxa Corporation·Product code LHI·March 8, 2011

    ExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set

    FDA Recall
    Terminated ·Baxa Corporation·Product code LHI·March 8, 2011

    ExactaMix EVA Container, 500mL, REF: 738, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set

    FDA Recall
    Terminated ·Baxa Corporation·Product code LHI·March 8, 2011

    ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set

    FDA Recall
    Terminated ·Baxa Corporation·Product code LHI·March 8, 2011

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018