BEUDAMED
    21 results · 20ms · Sources: EU EUDAMED, US FDA

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    SEALAPEX 4

    FDA 510(k)
    FDA Class 2 ·Dental

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109401·Zirlux Implant Analog

    NVJJB

    FDA UDI
    Nuvasive, Inc.·00887517062864·NVJJB Clips, DST

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361010661·PedFuse Reset, SLD, 6.0mm x 40mm

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100400·Assembly, Caddie, Curved Rods

    Zyphr

    FDA UDI
    STRYKER CORPORATION·04546540517449·4.0mm Zyphr Extended Round Fluted

    MICOR ANESTHESIA CONDUCTION KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HUMAN SERUM ALBUMIN (HSA)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 30, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862233110·INSTRUMENT TRAY, LOGIC CRC, SIZE 4

    MEDSTONE LITHOTRIPTOR

    FDA Adverse Event
    Malfunction ·HEALTHTRONICS, INC.·Product code LNS·June 12, 2017

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2013

    CRYSTALSERT

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code MSS·March 4, 2011

    ISOFLEX S

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

    STERIS

    FDA Adverse Event
    Malfunction ·VILEX·Product code HTY·April 6, 2005

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    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