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

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    Broncoflex Agile, Broncoflex Vortex, Screeni

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Bernafon

    FDA UDI
    Bernafon AG·05711584114766·CZ7 MNR T R, 2.4G NFM SABE DEMO CORAL 7 GPL

    UPSTREAM SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    AIA-2000

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·November 1, 2018

    RENEW RECEIVER

    FDA Adverse Event
    Injury ·ST. JUDE MED - NEUROMODULATION·Product code GZB·October 24, 2014

    AFFINITY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·July 12, 2011

    PROLENE HERNIA SYSTEM MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 9, 2013

    HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·November 6, 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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012