BEUDAMED
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    939UDX URINE PATHOLOGY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040054427·Strip Crown Forms Set

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040179413·FLEX- Double Sided Dimond burs

    intellijoint HIP®

    FDA UDI
    Intellijoint Surgical Inc·00628184003732·Femoral Disc, Ellipse

    Eclipse Pro

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522127243·ECLIPSE PRO,CABLE,PX,3 SNAP,MEDIUM

    MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA

    FDA 510(k)
    FDA Class 2 ·Neurology

    CEMENT IT! UNIVERSAL C&B

    FDA 510(k)
    FDA Class 2 ·Dental

    HEMICAP/UNICAP RESURFACING PROSTHESIS

    FDA Adverse Event
    Other ·ARTHROSURFACE, INC.·Product code HSD·December 7, 2012

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 5, 2025

    ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 29, 2018

    TOTAL ASR ACET IMP SIZE 48

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·March 12, 2013

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH LTD/ HUNTINGTON·Product code MFK·February 18, 2011

    BARD ACCESS SYSTEMS

    FDA Adverse Event
    Injury ·Product code DQO·February 19, 2008

    Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Ponsky "Pull" Placement Technique REF 000373, 20F, STERILE.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    BrightView XCT (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 XCT

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017

    BrightView XCT , Model Number 882482

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019

    BrightView XCT, Gamma Camera, Product Code 882482

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

    BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·September 14, 2016

    BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·November 6, 2013