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

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    AIRLIFE HEPA FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040014035·Zirlux 16+ B1 98.5X20

    Mesh

    FDA UDI
    Nuvasive, Inc.·00887517063496·Mesh, 20x30mm

    BLUE MERLIN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033245408·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112320·Tap, 4.75mm, Fixed Sleeve

    KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4

    FDA 510(k)
    FDA Class 2 ·Dental

    BONE BIOPSY NEEDLE

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 13, 2025

    ENDOTRACH TUBE 8229965 5PK 6.5MM EMG FLX

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·March 14, 2013

    ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 8, 2011

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 15, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 11, 2017

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code LCP·January 5, 2016

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code LCP·January 3, 2017

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·April 16, 2018

    Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.

    FDA Recall
    Terminated ·Product code HRY·April 22, 2011

    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013