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    UNI-THREAD SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074033099·BONE SCREW 7042640 20 DEG ILC 6.5X40 TI

    SDFlosser Trial Pack

    FDA UDI
    PRACTICON, INC.·00723896019528·SILVER DIAMINE FLUORIDE FLOSSER, TO DISPENSE AN...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809866681·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...

    ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FREEDOM AUTOMATIC FILM PROCESSOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 11, 2014

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 22, 2013

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 30, 2013

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 22, 2013

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 30, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 6, 2011

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013

    VITALITY 2 DR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    PKG, BLAKESLY BIOPSY FORCEPS, P/N 0250080292. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and 4535-674 41711, 510(k) #K052640

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·January 26, 2009

    Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System, Catalog/Model #882471, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·April 25, 2011

    Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·April 25, 2011

    Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164. The recalled GEMINI TF64 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·May 31, 2011

    Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174. The recalled GEMINI TF16 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·May 31, 2011