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

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    OPIATES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CoverLoc™ Volar Plate

    FDA UDI
    TORNIER, INC.·00846832001347·FULLY THREADED SCREW - CORTICAL

    Alleset

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918166735·Back Table Cover_100x150cm_Non-sterile_80ea/cs

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024090·Paddle Shaver, 14mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103140·Shaver, Closed, 14mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132140·Trial, TLIF, 27L OB CRV 7Deg, 14mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134140·Trial, TLIF, 27L OB STR 7Deg, 14mm

    DIMENSION CTNI CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·March 29, 2023

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    ARCHITECT IPTH

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code CEW·January 24, 2014

    UNKNOWN COOLSCULPTING SYSTEM

    FDA Adverse Event
    Injury ·ALLERGAN PLEASANTON·Product code OOK·November 4, 2021

    INTERLOCK¿-35

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRD·March 20, 2013

    8MM MCS TIP COVER ACCESSORY

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·March 10, 2011

    STAYFUSE

    FDA Adverse Event
    Other ·NEXA ORTHOPEDICS, INC.·Product code HWC·March 14, 2008

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015