BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    BostonSight IC Corneal Lens, BostonSight IC Scleral Lens

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FORMATK MAGMA PLATFORM LASER

    FDA Adverse Event
    Injury ·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019

    SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CORVIS ST

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FORMATK MAGMA PLATFORM

    FDA Adverse Event
    Malfunction ·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020

    CAPSURE SP 4024

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 8, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·June 17, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·September 8, 2008

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 5, 2026

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 5, 2026

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class I ·Terminated·Brainlab AG·January 27, 2016

    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