BEUDAMED
    14 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    SEPRACELL LYMPHOCYTE SEPARATION MEDIUM

    FDA 510(k)
    FDA Class 1 ·Hematology

    PageWriter

    FDA UDI
    Philips Medical Systems Hsg·00884838082007·PageWriter TC30 government bundle with trolley

    AZURE ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHOFIX INC.·Product code KWQ·October 31, 2013

    MX50T(MX50TQS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 5, 2012

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·October 7, 2010

    PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code DPS·January 9, 2019

    PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·February 27, 2019

    OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 8, 2012

    UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 8, 2012

    OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 8, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012