BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065630·INTRAORAL ELASTICS 2,5 oz 1/8" brown

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101090·Distractor, Smooth Paddle, Lordotic, 9mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101090·Distractor, Smooth Paddle, 9mm

    SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    FLUOROPERM 151-OK, PARAGON HDS 100-OK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VENTILATOR

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SYSTEMS INC·Product code CBK·March 25, 2009

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 16, 2025

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

    CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    TEMPERATURE/FLOW PROBE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 30, 2010

    CURRENT RF DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·September 15, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011

    NOVOTWIST 8 MM (30G)

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S, MS HJOERRING·Product code FMI·August 11, 2016

    BUBBLE CPAP SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 31, 2012

    SINGLE-HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 22, 2011

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (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