BEUDAMED
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    Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814220·GENUMEDI PT SILVER L V

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192794·22mm X 150mm Stem Pilot

    Symmetry Weitlaner

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482045251·Symmetry® Retractor, Weitlaner, Blunt, 3x4 Pron...

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517086171·

    ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

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

    Pilot Elite Diode Laser

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·May 18, 2004

    COONRAD/MORREY TOTAL ELBOW REPLACEMENT SET BUSHINGS & PINS

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDC·November 19, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2013

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·April 25, 2018

    St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·Abbott·May 1, 2019

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020