BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    MISSION COMPLETE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000628·2.4mm x 6mm Locking Screw

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425495627·SUTURE REMOVAL TRAY

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102060·Shaver, Open, 6mm

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0602000·Tray base, 2"

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023895·PADDLE SPREADER, 6MM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694062756·2.4 x 6mm Locking Screw Sterile Qty 2

    DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOURGLASS

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MQP·June 16, 2014

    GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2013

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011

    AS INVERSE HUMERAL PE-INLAY 40-3

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSD·April 11, 2013

    OLYMPUS

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·June 3, 2008

    SYNCHRON® LX20 CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CGA·April 15, 2011

    TRULIANT TIB IMP PS INSERT SZ 4 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 5, 2023

    GEMSTAR 1.2 MICRON FLTR 244CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 5, 2013

    Thermoplastic templates, single tooth Catalog Number: 040.526

    FDA Recall
    Terminated ·Straumann Manufacturing Inc.·Product code DZJ·January 30, 2006

    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024