BEUDAMED
    26 results · 27ms · Sources: EU EUDAMED, US FDA

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    Multi-Drive Interference Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    StarDental Instrument Solutions

    FDA UDI
    DENTALEZ, INC.·D7022004280·CLASSIQUE DIA INSTRUMENTS 770-9P

    INBONE

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420196590·Stem Extraction Tool

    Intraoral Scan Body NP

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059075083·

    DIXI 2

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDOPATH DILATING TIP TROCAR, MODEL #512XD

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

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 3, 2022

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·January 31, 2017

    DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·August 11, 2011

    TOTAL ASR ACET IMP SIZE 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·July 1, 2013

    INSERT-HANDLE F/ETN RADIOLUC SHORT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·November 16, 2021

    CATHETERS & CANNULAE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·October 1, 2019

    SINGLE USE GUIDWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code OCY·July 14, 2020

    DRIVING CAP WITH HANDLE ADAPTER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·November 16, 2021

    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018