BEUDAMED
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    SPIKED WASHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040010990·Zirlux 16+ B1 100X25

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189720·LEVAMED ACTIVE ANKLE SUP BLACK L III

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344569·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344521·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344583·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344552·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344576·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344545·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033344538·

    ISLAND BIOSURGICAL BNS KIT #3

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

    AMBU GEL, HYDROGEL BURN DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    THORACIC GRASPER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·March 19, 2013

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·March 9, 2011

    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

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018