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

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    MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056110·Zirlux Multi Anterior A1,98.5X16

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810123101·Maxima Gutta Percha CC 20/Vl

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040140847·Maxima Gutta Percha CC 20/Vl

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040099940·Maxima Gutta Percha CC 20/Vl

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103100·Shaver, Closed, 10mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024052·Paddle Shaver, 10mm

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0113100·Decorticating Planer

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·May 18, 2021

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·June 17, 2021

    MODIFICATION TO TRIDENT ALL POLY CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDIOBEEPER CB12/12, MODEL CB12/12

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 14, 2025

    ZIMMER MMC CUP 56 MM/48 MM CODE N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 12, 2013

    MOST STEM DISTRACTOR

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·February 1, 2011

    PRSVN ALPOLY TIB LMRL S3 9.5MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC·Product code HRY·February 11, 2008

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·August 16, 2021

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022