BEUDAMED
    20 results · 29ms · Sources: EU EUDAMED, US FDA

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    VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6919030613·TENACULUM SCHROEDER 10 IN

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0360130·Modular Tip, Bifid, Offset Right

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106130·Trial, 26 x 13mm, 8 Degree, Tapered, Straight

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482051085·Symmetry® Scissors, Operating, Straight, Sharp/...

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481477047·

    CSK-TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·June 6, 2017

    MAGELLAN-2200, MODEL 1

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138296·Broach, 30 X 26, 13mm Height 16° Hyperlordotic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137398·Trial, 30 X 26, 13mm Height 16° Hyperlordotic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136285·Ti-6Al-4V ALIF Implant 30 X 26, 13mm Height 16°...

    ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code BSP·November 21, 2019

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·March 22, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 9, 2011

    QUANTUM MAVERICK MR BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 16, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·July 5, 2023

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013