BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Hillrom™

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761976023·Trumpf Medical/Medizin Pad shoulder basis segme...

    Pads

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761968967·Pad shoulder basis segment G

    RMO

    FDA UDI
    Rmo, Inc.·00885797099884·IMPRES TRAY KIT MX/MN ASST 30

    GETTIG GUARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 4, 2020

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 26, 2013

    NEUROMONITOR BASIC KIT

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code GWM·April 22, 2011

    PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·July 24, 2008

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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