BEUDAMED
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    APPLIED URETERAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040160975·Channels Flex 31mm 30.06

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221062635·Mini Uni-Twin(TM) Bracket APC(TM) II UL2 10T/9A...

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717107344·Midway Select T-Mixer HP Mixing Tips Green/Teal...

    APC™ PLUS Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221093653·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL2 10T/...

    Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear

    FDA Enforcement
    Class II ·Terminated·Wal Mart Stores, Inc·June 25, 2014

    YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA

    FDA 510(k)
    FDA Class 1 ·Dental

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·March 26, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 16, 2011

    CONMED

    FDA Adverse Event
    Injury ·CONMED ELECTROSURGERY·Product code GEI·March 28, 2008

    ONYX

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·November 8, 2024

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·November 8, 2024

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014