BEUDAMED
    20 results · 30ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    12F Tri-Flow Triple Lumen Catheter

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

    FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TUBE SET FOR SUCTION SINGLE-USE

    FDA Adverse Event
    Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·December 2, 2019

    BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·June 12, 2018

    BD VACUTAINER® LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·June 8, 2018

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 2, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 21, 2013

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·July 8, 2011

    13 X 75 MM 3 ML BD VACUTAINER® PLASTIC PST/PST II TUBE

    FDA Adverse Event
    Injury ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 23, 2016

    13 X 75 MM 3 ML BD VACUTAINER® PLASTIC PST/PST II TUBE

    FDA Adverse Event
    Injury ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 23, 2016

    13 X 75 MM 3 ML BD VACUTAINER® PLASTIC PST/PST II TUBE

    FDA Adverse Event
    Injury ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 23, 2016

    UNSPECIFIED BD¿ LIHEP (NO GEL) COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·April 30, 2018

    UNSPECIFIED BD¿ LIHEP (NO GEL) COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 1, 2018

    UNSPECIFIED BD¿ LIHEP (NO GEL) COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·April 27, 2018

    UNSPECIFIED BD¿ LIHEP (NO GEL) COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 1, 2018

    Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012

    MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020