BEUDAMED
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    OTIS -C PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ITL Essential Laparoscopic Quiver Extendable

    FDA UDI
    ITL ASIA PACIFIC SDN. BHD.·19555240400854·Extendable laparoscopic quiver, PVC loop, polyp...

    DEBAKEY VASCULAR CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896096547·DEBAKEY CASCULAR CLAMP ANGLED TIP

    DEBAKEY VASCULAR CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921006040·DEBAKEY VASCULAR CLAMP ANGLED JAW

    HS Stand. Burr, Ø5.0x150, 80k

    FDA UDI
    Bien-Air Surgery SA·17630055507454·

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869639989·MOSS Hook Inserter

    HYBERNITE RAINOUT CONTROL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 24, 2022

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 8, 2013

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 13, 2011

    3.8 FLEXIBLE DRILL BIT

    FDA Adverse Event
    Injury ·DEPUY·Product code HTW·August 5, 2008

    NAVLOCK TRACKER UNIVERSAL ORANGE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code OLO·November 25, 2015

    HANDLE CEV10195R DIA 5MM ANG W/ RATCHET [MXI/XOM]

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code GEI·February 7, 2013

    HANDLE CEV10195R DIA 5MM ANG W/ RATCHET [MXI/XOM]

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code GEI·February 7, 2013

    Quickcable Autoclaveable Cable Electrode Cable

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·May 21, 2004

    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018