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

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    SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SENSATION PLUS 8FR. 50CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 10, 2022

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

    SENSATION 7FR. 34CC IAB

    FDA Adverse Event
    Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021

    5530 3L SYRINGE

    FDA UDI
    HANS RUDOLPH, INC.·00874750008452·5530 3L SYR;MGC 704001-004

    CLEARVISION DR 7000F

    FDA 510(k)
    FDA Class 2 ·Radiology

    CSIST DICOM GATEWAY/IMAGE MANAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL4¿, 63 CM LENGTH, 8F

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code DYB·December 12, 2024

    OSS POLY LOCK PIN

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·May 14, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

    APPOSE ULC 35 WIDE SKIN STAPLER

    FDA Adverse Event
    Injury ·NELLCOR PURITAN BENNETT M·Product code GDT·May 25, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 1, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 1, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 2, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 16, 2023

    CHECK-IT

    FDA Adverse Event
    Malfunction ·PFIZER, INC.·Product code QJR·May 8, 2023

    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·January 16, 2013

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 7, 2022

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 14, 2012