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

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    Masimo O3 Regional Oximeter System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Richard Wolf GmbH·04055207014370·BRONCHOSCOPE-TUBE ID 7.5MM model Wolf, OD 8.5m...

    NA

    FDA UDI
    Synthes GmbH·10886982153685·4.5MM CORTEX SCREW 72MM

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551114109·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1201-1 X...

    HOLOSCOPE-i

    FDA 510(k)
    FDA Class 2 ·Radiology

    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDTRONIC ICD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·May 28, 2024

    UNSPECIFIED BD ALARIS PUMP SET

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FPA·April 16, 2021

    UNSPECIFIED BD ALARIS PUMP SET

    FDA Adverse Event
    Death ·BECTON DICKINSON·Product code FPA·April 14, 2021

    SMALLBORE IV EXTENSION SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL INC.·Product code FPA·November 18, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 24, 2014

    FOUNDATION KNEE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code JWH·August 2, 2011

    TRIDENT ALUMINA INSERT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MRA·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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