BEUDAMED
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    INPLANT ORTHODONTIC ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741127915·Catheter Placement Kit

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964005761·CUSTOM PROCEDURE KIT

    Brite-Gear

    FDA UDI
    ORMCO CORPORATION·00889989023657·Facebow MINSHORT#3 044 BLACK

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 12, 2024

    MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DRG AURICA ELISA TESTOSTERONE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·December 18, 2024

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 15, 2024

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 6, 2024

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 15, 2024

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·March 12, 2013

    X8000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·February 3, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 21, 2008

    EDWARDS LOCKING SYRINGE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·June 16, 2023

    EDWARDS LOCKING SYRINGE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES LLC·Product code MAV·March 29, 2022

    Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024