BEUDAMED
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    TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Indus®

    FDA UDI
    SPINEFRONTIER, INC.·00190361039471·7mm Trial Drill Guide, Lordotic

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033328750·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112070·Tap, Cannulated, 5.5 mm

    Matira

    FDA UDI
    Kalitec Direct LLC·B073K0157070·Trial Drill Guide Tube, 7mm

    ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TROCAR

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DYB·June 5, 2018

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 23, 1997

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 19, 2013

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE

    FDA Adverse Event
    Other ·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·March 3, 2011

    ACCU-CHEK INFORM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·March 10, 2008

    MOSAIC MITRAL BIOPROSTHETIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·April 21, 2022

    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

    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

    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