BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    VISULAS YAG II

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDTRONIC EXTENDED INFUSION SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 15, 2024

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

    VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DRX HBA1C - FOR PRESCRIPTION HOME USE

    FDA 510(k)
    FDA Class 2 ·Hematology

    UNO EWIS BLUE 80/9 HCAP 3-PK INT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 20, 2024

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

    PALACOS R BONE CEMENT

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code LOD·March 12, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 12, 2014

    RA CATH SET: 20 GA X 1-3 /4

    FDA Adverse Event
    Injury ·ARROW INTERNATIONAL INC·Product code DQO·February 15, 2008

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·May 14, 2025

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013

    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

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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