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

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    AHI System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Synthes GmbH·10886982152268·5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE...

    TAPAS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCALPFIX CLIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    OVERJET CARIES ASSIST

    FDA Adverse Event
    Malfunction ·OVERJET·Product code MYN·February 18, 2025

    COLLEAGUE PRE-P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

    TRUETRACK

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·September 24, 2018

    UNKNOWN PARIETENE MESH PRODUCT

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·June 7, 2024

    ILS 33MM, CURVED

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 26, 2020

    RG3

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·January 27, 2025

    CORSAIR PRO

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQY·January 28, 2025

    CONQUEST PRO

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·January 28, 2025

    FIELDER XT-A

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·January 28, 2025

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 5, 2021

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025