BEUDAMED
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    ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694044196·2.3mm x 4mm Mandible Safety Screw

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450255704·

    Titan Modular Shoulder System 2.5

    FDA UDI
    Smith & Nephew, Inc.·00885556859841·TSS HUMERAL INSTRUMENT TRAY 1 - ...

    Titan™

    FDA UDI
    Ascension Orthopedics, Inc.·10381780243281·Titan™ Total Shoulder System The Titan Total Sh...

    ACCUMAP AUTOMATIC PERIMETER

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADC 656 ELECTRONIC STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 3, 2013

    ONE TOUCH ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 1, 2008

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM.

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 18, 2011

    INNOVA 3100-IQ

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS SCS·Product code OWB·May 30, 2017

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

    Opthalmic Laser, product number 8065-5000-1

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code HQF·April 9, 2004

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    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

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025