BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO OUTBACK CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QG-80

    FDA UDI
    CARESTREAM HEALTH, INC.·60889974000467·QG-8000-3 ODYSSEY GEN 80KW

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101170·Distractor, Smooth Paddle, Lordotic, 17mm

    NA

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·March 7, 2012

    MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GUIDANT AXIUS CORONARY SHUNT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·September 9, 2010

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    ISOFLEX S

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    ON-Q C-BLOC

    FDA Adverse Event
    Other ·I-FLOW CORP.·Product code MEB·March 14, 2008

    BD VACUTAINER SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 9, 2021

    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 19, 2012

    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

    FDA Enforcement
    Class III ·Terminated·DeVilbiss Healthcare LLC·July 9, 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