BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    EONS Nitrile Examination Gloves Powder Free

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ABBOTT TACTICATH

    FDA Adverse Event
    Malfunction ·ABBOTT ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.·Product code OAE·December 20, 2023

    GLP TRACK END

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 18, 2026

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 27, 2008

    COLLEAGUE PRE-P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·July 9, 2013

    GLP CENTRIFUGE MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·July 10, 2025

    GLP CENTRIFUGE MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024

    GLP CENTRIFUGE MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 28, 2025

    GLP ALIQUOT MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·August 1, 2025

    GLP TRACK END

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 1, 2026

    GLP TRACK END

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·November 14, 2024

    GLP CENTRIFUGE MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024

    GLP CENTRIFUGE MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·June 19, 2025

    GLP BULK LOADER MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 12, 2025

    GLP LOADER MODULE

    FDA Adverse Event
    Injury ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 5, 2025

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017