BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    Entuit PEG, Entuit PEGJ

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

    iTero Lumina DOA Cart

    FDA UDI
    Align Technology, Inc.·00816063021452·Replacement package of iTero Lumina scanner in ...

    WILSON-COOK ULTRASOUND BIOPSY NEEDLE

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

    HOLOGIC VISCERAL FAT SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUICK-CORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FCG·September 4, 2018

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 30, 2014

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON·Product code FTL·July 2, 2013

    LIFE SCOPE G9

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024

    LIFE SCOPE G9

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023

    Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    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