BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Spectraline™ 20mL Syringe

    FDA UDI
    Merit Medical Systems, Inc.·00884450270882·

    MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·April 10, 2019

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·April 8, 2019

    SELOX JT 45

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·March 19, 2013

    NEXGEN CR PEGGED TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 2, 2011

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·May 1, 2014

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·September 15, 2022

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·April 28, 2014

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·March 27, 2014

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024