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

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    GLOBAL ICON Stemless Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD PLASTIPAK¿SYRINGE LUER-LOK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 13, 2018

    SMI CARDIOVASCULAR PACH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    22 G X 1 1/2 IN. BD INTEGRA¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code MEG·October 17, 2017

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

    BACTISEAL UNIVERSAL SHUNT, M

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·August 11, 2011

    OPTEASE RETRIEVABLE VENA CAVA FILTER

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code DTK·July 3, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 16, 2023

    BD PLASTIPAK¿ SYRINGE LUER-LOK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 11, 2017

    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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    DRX Revolution Mobile X-Ray System

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