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    cvi42 Auto Imaging Software Application

    FDA 510(k)
    FDA Class 2 ·Radiology

    POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    250E NDL 23 X 1 A

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FMI·October 20, 2008

    SERIES 20000 LEGACY

    FDA Adverse Event
    Other ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 23, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017