BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    KONICAMINOLTA DI-X1

    FDA 510(k)
    FDA Class 2 ·Radiology

    REPROCESSED ENDOSCOPIC ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ANGIOSCULPT PTA SCORING BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEEDLE 18X1-1/2 BLUNT FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·March 25, 2025

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Injury ·ANGIOSCORE, INC·Product code LIT·March 29, 2016

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·October 20, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 16, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·July 9, 2013

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC·Product code LIT·November 26, 2015

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013

    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