BEUDAMED
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    Phoenix Elastics

    FDA UDI
    PHOENIX ORTHODONTICS INC·05060772892604·LATEX NEON GREEN A 1-8 MEDIUM 3.5 OZ ELASTICS 1...

    SINGLE USE ASPIRATION NEEDLE

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code FCG·May 19, 2025

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    FDA Adverse Event
    Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·May 30, 2024

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    FDA Enforcement
    Class II ·Terminated·Abaxis Inc·June 24, 2020

    AUTOTOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION-SPENCER·Product code KNS·March 3, 2009

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 30, 2012

    AUTOCLAVABLE CAMERA HEAD

    FDA Adverse Event
    Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·May 2, 2025

    Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJF·May 21, 2007

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    FDA Recall
    Terminated ·Abaxis Inc·Product code JJG·December 11, 2019

    TAPERGUARD

    FDA Adverse Event
    Malfunction ·MMJ SA DE CV (USD)·Product code BTR·September 4, 2024

    SHILEY

    FDA Adverse Event
    Malfunction ·COVIDIEN AG JUAREZ (MMJ)·Product code BTR·September 12, 2025

    UNK_QDOT MICRO

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code OAD·August 30, 2021

    UNK_SMART TOUCH UNIDIRECTIONAL SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·August 30, 2021

    NGAGE NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FFL·July 28, 2024

    UNK_THERMOCOOL SF NON NAV

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code OAD·August 30, 2021

    HARMONIC ACE + 7

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 25, 2023

    EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    FDA Adverse Event
    Injury ·SHIRAKAWA OLYMPUS CO., LTD.·Product code PSV·May 19, 2025

    UNKNOWN CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code JXG·March 18, 2025

    UNK - PSI IMPLANTS: TRAUMA

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·March 31, 2026

    INTRALASE

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HNO·August 23, 2019