BEUDAMED
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    ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Vereos PET/CT

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838059559·

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    TruShot with Y-Knot All-Suture Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 18, 2014

    RX CYTOLOGY BRUSH

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FDX·July 1, 2015

    MP40 INTELLIVUE PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 20, 2010

    AVAN TAP CORT SCR SS 4.5X26MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X58MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X48MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X56MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X60MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X20MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    AVAN TAP CORT SCR SS 4.5X52MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    M2A ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

    Vereos PET/CT Model # 882446, computed tomography x-ray system

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 24, 2019

    Vereos PET/CT Model # 882446, computed tomography x-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPS·May 1, 2021

    Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 10, 2019