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

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    Surgical Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Diapact®

    FDA UDI
    B. BRAUN MEDICAL INC.·04039239047346·Plasma Exchange (PEX) Tubing Set

    NA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295086444·CANAL REAMER 14mm DIA

    SYNTHES ANTEROLATERAL CALCANEAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IBAG

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

    BD VACUTAINER® TRACE ELEMENT SERUM PLUS TUBE, 6.0ML, 13X100MM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·November 27, 2017

    MBT CEM KEEL TIB TRAY SZ3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·October 22, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    ARTICULEZE M HEAD 36MM -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·July 8, 2013

    Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

    FDA Enforcement
    Class II ·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021

    Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Technologies Ltd.·November 27, 2024

    Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

    FDA Enforcement
    Class II ·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021

    SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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