BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    Trevo Trak 21 Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116022663·Dornier 600 µm Single-Use SMA Diode Laser Fiber...

    ZOLL E SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORP (INTEGRA-OHIO)·Product code GFD·December 4, 2015

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 8, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·Product code LZG·November 9, 2015

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·April 25, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·July 7, 2022

    Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

    FDA Enforcement
    Class II ·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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