BEUDAMED
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    IDS-iSYS CTX-I Calibration Verifiers

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814275·GENUMEDI PT SILVER R IV

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517577610·CoRoent Ant TLIF PEEK, 14x13x32mm 4°

    SMALL Y PLATE- 4 HOLES

    FDA UDI
    Biomet Orthopedics, LLC·08426750820064·

    PRECISION LIQUID OXYGEN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AIDA WITH DICOM AND HL7 INTERFACE

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

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·October 6, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 3, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 29, 2011

    RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

    FDA Recall
    Terminated ·Abbott Vascular·Product code NIM·September 10, 2010

    RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

    FDA Recall
    Terminated ·Abbott Vascular·Product code NIM·September 10, 2010

    RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number: 0072061 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

    FDA Recall
    Terminated ·Abbott Vascular·Product code NIM·September 10, 2010