BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Omni Foot and Ankle Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Aline Ablation Intelligence

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENLUXTRA HUMIFIBER WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    OT VERIO IQ METER

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

    N/A

    FDA Adverse Event
    Malfunction ·Product code JOH·August 15, 2011

    GYNECARE TVT OBTURATOR SYSTEM

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

    UNKNOWN SALINE IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·June 19, 2018

    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