BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Revitive Medic Coach (Model Number 5575AQ)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CANDELA SMOOTHBEAM LASER SYSTEM

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

    KNIGHTSTAR 330

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·October 22, 2008

    SYSTEM 5 SAGITAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·August 4, 2011

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABS·Product code FTM·July 3, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 15, 2017

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 29, 2018

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    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