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

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    TOKUYAMA REBASE II

    FDA 510(k)
    FDA Class 2 ·Dental

    Sempra Class A21 - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588626413·Sempra Class A21 - 18 Metal

    FAS ENDOLUMINAL BRUSH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MARGRON STEM (K032641)

    FDA Adverse Event
    Injury ·PORTLAND ORTHOPAEDICS PTY LTD·Product code KWY·May 31, 2005

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Injury ·MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC)·Product code LMH·January 18, 2011

    XENIUM XPH

    FDA Adverse Event
    Malfunction ·NIPRO CORPORATION *USD*·Product code KDI·March 27, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 17, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 31, 2008

    COOK-SWARTZ DOPPLER PROBE

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code ITX·September 6, 2015

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 13, 2025

    Speed Stitch Needle Cassette

    FDA Enforcement
    Class II ·Ongoing·ArthroCare Corporation·September 30, 2020

    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

    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