BEUDAMED
    17 results · 32ms · Sources: EU EUDAMED, US FDA

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    MARVEL™ Growing Rods

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VASCULAR SONO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    TRIAGE CARDIAC PANEL

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code MMI·October 22, 2008

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KXA·August 12, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 9, 2013

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code BWC·September 4, 2019

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021