BEUDAMED
    12 results · 31ms · Sources: EU EUDAMED, US FDA

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    CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    iTotal® Patella Sizer

    FDA UDI
    Conformis, Inc.·00850268007163·iTotal® 38mm Patella Sizer Reusable Instrument

    Clamp, Hysterectomy, model Z 30.5cm slightly curved

    FDA UDI
    Geister Medizintechnik GmbH·04057034373255·Clamp, Hysterectomy, model Z 30.5cm...

    QUADRA H LAT FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JDI·December 28, 2009

    PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ILT DEFLECTING CATHETER, MODEL C114ND1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TENDRIL SDX

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·April 26, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 6, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2008

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024