BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    NeuroLine Disposable Cranial Perforator with Hudson end

    FDA 510(k)
    FDA Class 2 ·Neurology

    RENAISSANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 5, 2021

    BD¿ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FMI·February 5, 2019

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·October 20, 2008

    AZUR PERIPHERAL COIL SYSTEM

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code KRD·March 12, 2013

    DREAMTOME¿ RX 44

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·August 16, 2011

    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