BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    ZOLL E SERIES WITH INTIBATION ASSIST OPTION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    n/a

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000884499·GUIDE 7080903 FIXED DRILL GUIDE

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994234056·GUIDE 7080903 FIXED DRILL GUIDE

    ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TRI-FIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMPLETE BRAIN IMC PROBE KIT

    FDA Adverse Event
    Malfunction ·GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK GMS, M·Product code GWM·March 17, 2004

    COMPLETE BRAIN IMC PROBE KIT

    FDA Adverse Event
    Malfunction ·GESELLSCHAFT FUR MEDIZINISCHE SONDER·Product code GWM·March 17, 2004

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 19, 2021

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZE·May 30, 2009

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 26, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 6, 2011

    CORTICAL BONE SCR 38MM

    FDA Adverse Event
    Injury ·DEPUY ACE S.A. 'R.L.·Product code HSB·July 22, 2008

    LICOX OXYGEN MICRO-PROBE

    FDA Adverse Event
    Malfunction ·GESELLSCHAFT FUR MEDIZINISCHE SONDER·Product code GWM·January 22, 2004

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Recall
    Terminated ·Philips Healthcare·Product code NCX·January 13, 2014

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·February 5, 2014

    Portex 1st Response Adult Manual Resuscitators Ref: 8500P

    FDA Recall
    Terminated ·Sims Portex Inc.·Product code BTM·November 15, 2002

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the 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. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    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