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    ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Preat

    FDA UDI
    Preat Corporation·00842092183755·ASC Zimmer? TSV-compatible 4.5mm X 9mm Non-Enga...

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741043833·Catheter Placement Kit

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832021680·GLENOID DRILL/REAMER WRENCH

    I/A Tubing

    FDA UDI
    I.C. MEDICAL, INC.·00817688021308·

    PTERYFIT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 19, 2024

    DuoFLEX® Coil Suite

    FDA UDI
    M R Instruments, Inc.·00857371006243·The 24cm Right Coil Assembly is a part of the D...

    Trulink

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522122552·CABLE ASSY,IBP,SINGLE,ABBOTT,ROHS

    DuoFLEX® Coil Suite

    FDA UDI
    M R Instruments, Inc.·00857371006236·The 24cm Left Coil Assembly is a part of the Du...

    CRANIAL DRILL

    FDA 510(k)
    FDA Class 2 ·Neurology

    OLYMPUS SONOSURG TROCAR XT3900 SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    BASE UNIT SERVO-U

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·March 22, 2024

    Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Recall
    Open, Classified ·Datascope Corporation·Product code DSP·July 27, 2020

    MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0295-01 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0295-02 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0295-03 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0295-05 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES AND APA (CHINA) D684-00-0295-06 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA D684-00-0295-07 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK (APA) - INDIA D684-00-0295-08 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0295-09 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) (TURKEY) D684-00-0295-10 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0295-01U MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA, US ONLY D684-00-0295-02U MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES D684-00-0294-01 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) D684-00-0294-02 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0294-03 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (CHINA) D684-00-0294-05 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES AND APA (CHINA) D684-00-0294-06 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA D684-00-0294-07 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK (APA) INDIA D684-00-0294-08 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (TURKEY) D684-00-0294-09 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) (TURKEY) D684-00-0294-10 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES, US ONLY D684-00-0294-01U MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA, US ONLY D684-00-0294-02U PACKAGED INSERTION KIT - MEGA 7.5 Fr. 30/40 cc IABs D884-00-0019-21

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·June 23, 2023

    Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corporation·September 2, 2020

    HEMOSTAR

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code MSD·December 29, 2024

    HEMOSTAR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (BASD) -3006260740·Product code MSD·December 30, 2024

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 12, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·February 18, 2011

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·EBI·Product code KWQ·February 14, 2008