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

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    EQUIPMENT DRAPES

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

    Harvard Cement normal setting, Single powder, Shade 8

    FDA UDI
    Harvard Dental International GmbH·EHAR70025081·Zinc phosphate cement

    RMO

    FDA UDI
    Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST

    Natus

    FDA UDI
    XLTEK·00382830020848·P32 - STIM POD 2 (A-D) - 10'

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103537·BRACKET NARROW TWIN LEFT LATERAL 022 TQ=+14 A=+...

    Hyalo4 Care Hydrogel, 25g

    FDA UDI
    FIDIA FARMACEUTICI SPA·M713494440025080·Hydrogel wound dressing, 25g, Professional Sample

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148813·Straight Implant Trial 25mm x 9mm x 8mm

    LASERSKIN DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    THERMOFLEX SYSTEM

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

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 30, 2024

    PORTEX GENERAL ANESTHESIA CIRCUITS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 12, 2013

    LOCKING SCREW VARIAX FULL THREAD 3.5MM / L55MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS SELZACH·Product code KTT·February 16, 2011

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·February 26, 2008

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·September 20, 2022

    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

    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