BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    EdgePro

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

    ANGIOJET ULTRA DVX THROMBECTOMY SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·September 6, 2023

    URETEX SUP URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·May 10, 2013

    ASR ACETABULAR CUPS 50

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

    6 SHOOTER SAEED MUTI-BAND LIGATOR

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code MND·October 24, 2014

    BD ULTRA-FINE¿ MINI PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·January 5, 2022

    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