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

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    EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964023024·The ENDO CARRY-ON Procedure Kit contains all of...

    CAMLOG

    FDA UDI
    Preat Corporation·00842092175316·Titanium Scan Body for CAMLOG Screw-Line 3.8mm

    QUASAR

    FDA UDI
    Modus Medical Devices Inc·G34350033410·Split Sphere w- Gold Seeds_45x2

    DR5000 DEDICATED CHEST X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    THERMAL CAUTERY UNIT, MODEL 150

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·February 23, 2021

    DEXTRUS 4135

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·February 13, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·March 1, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP.·Product code NBW·February 27, 2008

    OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 18, 2023

    NUVASIVE HELIX ACP SYSTEM

    FDA Adverse Event
    Malfunction ·NUVASIVE, INC.·Product code KWQ·June 1, 2022

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·May 28, 2019

    REPICCI II UNICONDYLAR FEMORAL 45 MM LM/RL

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code HRY·April 21, 2017

    "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·June 1, 2018

    "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·June 1, 2018

    REPICCI II UNICONDYLAR KNEE TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code HRY·April 21, 2017

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018