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

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    S-TEST CREATININE (CRE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014604305·RECTANGLE TABLE PAD DELUXE WITH VELCRO KIT

    Altus Spine Pedicle Screw System

    FDA UDI
    Altus Spine, LLC·00843210132204·TA25 Locking Driver

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450047392·

    Disposable Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935100836·

    MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPLINE DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·February 24, 2017

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code NIO·July 25, 2017

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 26, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 6, 2011

    COBLATOR II PLASMA WAND

    FDA Adverse Event
    Other ·ARTHROCARE CORP.·Product code GEI·July 17, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025

    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

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (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

    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