BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    Air Relax Pro Model AR-4.0

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TLC Uni Knee Meniscal Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215077525·

    MACHNET CAROTIDS COIL ARRAY ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·Radiology

    SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2

    FDA 510(k)
    FDA Class 2 ·Hematology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014

    SIZE4 RHEAD LATERAL STEM AND RADIAL HEAD

    FDA Adverse Event
    Injury ·SMALL BONE INNOVATIONS·Product code JDB·April 4, 2008

    RESOLUTION CLIP CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·July 9, 2013

    ELECSYS TSH ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·May 18, 2017

    ELECSYS TSH ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·April 26, 2017

    COBAS E 411 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 3, 2017

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026

    DRX Revolution Mobile X-Ray System

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