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

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    ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE

    FDA 510(k)
    FDA Unclassified ·Unknown

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040011652·Zirlux 16+ B3 95X14

    CORINNE MCCORMACK INC.

    FDA UDI
    FGX INTERNATIONAL INC.·00193033321263·

    CORINNE MCCORMACK INC.

    FDA UDI
    FGX INTERNATIONAL INC.·00193033321287·

    CORINNE MCCORMACK INC.

    FDA UDI
    FGX INTERNATIONAL INC.·00193033321270·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011026·PedFuse RespondX, CNL, 5.0mm x 30mm

    INSET II

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 13, 2026

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112300·Tap, 8.5mm Cortical, SNI1

    M-5LEO(II) Lyse

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904093147·

    MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    GC FUJICEM

    FDA 510(k)
    FDA Class 2 ·Dental

    HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code KWZ·September 26, 2016

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·March 19, 2013

    OPUS SMARTSTITCH M-CONNECTOR

    FDA Adverse Event
    Other ·ARTHROCARE CORP.·Product code KOG·March 2, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 11, 2008

    Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018

    CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014