BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    FUJIFILM Ultrasonic Endoscope

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

    INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    F20

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026

    FLOW-IT

    FDA Adverse Event
    Injury ·PENTRON CLINICAL·Product code EBF·April 7, 2015

    TRUWAVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 28, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025

    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

    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

    Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF procedure.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·December 26, 2018

    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