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

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    HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS

    FDA 510(k)
    FDA Class 2 ·Hematology

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101130·Distractor, Smooth Paddle, Lordotic, 13mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101130·Distractor, Smooth Paddle, 13mm

    AUTOSOFT 90

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 19, 2025

    AUTOSOFT 90

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 20, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 6, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 6, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 6, 2025

    SURSHIELD WINGED INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 5, 2025

    ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·March 19, 2013

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·March 1, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIAYLSATOREN GMBH·Product code MSF·March 10, 2008

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014