BEUDAMED
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    TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Oticon

    FDA UDI
    Oticon A/S·05707131165138·K13, BTE 13 P CNB

    MicroScan

    FDA UDI
    Beckman Coulter, Inc.·15099590655846·MicroScan 40% Potassium Hydroxide - 250ml

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111347177·DRESSING JAR 4 3/4 QT W/COVER

    Sklar

    FDA UDI
    SKLAR CORPORATION·30649111098158·DRESS JAR 4.75QT W/COVER PK 12

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517103335·

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517103359·

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517103342·

    BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TENS CARE, MODEL XL-Y3

    FDA 510(k)
    FDA Class 2 ·Neurology

    VELA VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL·Product code CBK·December 26, 2019

    VELA VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL·Product code CBK·January 22, 2020

    SHAMROCK

    FDA Adverse Event
    Malfunction ·WINFIELD MEDICAL INDUSTRIES·Product code JKA·January 9, 1998

    VELA VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL·Product code CBK·November 27, 2019

    VELA VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL·Product code CBK·February 9, 2021

    PORTEX PERCUTANEOUS KIT WITH BLUSELECT TRACH TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL CZECH REPUBLIC A. S·Product code BTO·September 24, 2024

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·May 20, 2011

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    FDA Adverse Event
    Malfunction ·MEDLINE INDUSTRIES, INC.·Product code OHG·July 25, 2008

    smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/090; 3) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect trach tube, Item Number 101/541/070; 4) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect trach tube, Item Number 101/541/080; 5) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect trach tube, Item Number 101/541/090; 6) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect trach tube, no forceps, Item Number 101/543/070; 7) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect trach tube, no forceps, Item Number 101/543/080; 8) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect trach tube, no forceps, Item Number 101/543/090; 9) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect SuctionAid trach tube, Item Number 101/891/070; 10) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect SuctionAid trach tube, Item Number 101/891/080; 11) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect SuctionAid trach tube, Item Number 101/891/090; 12) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 7.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/070; 13) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/080; 14) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/090; 15) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/070; 16) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/080; 17) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/090

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTO·June 7, 2024