BEUDAMED
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    HEMATOXYLIN SOLUTION

    FDA 510(k)
    FDA Class 1 ·Hematology

    Active™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788210620·4 Level Active Plate Caddy

    Jelco

    FDA UDI
    ICU MEDICAL, INC.·15019517050066·

    Suction Cannula

    FDA UDI
    KOROS U.S.A., INC.·10840199535108·Mini Thoracatomy Suction Cannula 4.75mm Diamete...

    TREPHINE

    FDA UDI
    Biomet Orthopedics, LLC·00887868048296·

    CHITO-SEAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code GZB·May 9, 2014

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 6, 2012

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·August 27, 2010

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022