BEUDAMED
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    COCR RODS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bur PM2-70 80K steel Ø3.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055512953·

    Oticon

    FDA UDI
    Oticon A/S·05707131165268·ACPR, ITE VC AT WL R BE ACTO PRO

    BECK DEBAKEY CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921007880·BECK DEBAKEY CLAMP DOUBLE ANGLED JAW

    BUNT FORCEPS HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049710·BUNT FORCEPS HOLDER RING LOOP END

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494463587·Endoscopic Kerrison Punch D 4.0mm, 90°, WL 150mm

    SIMPLICITY SOFT QD EASY INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APEX MODULAR HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

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

    VERCISE GENUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·September 7, 2022

    POWERLINK SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·June 17, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013

    530G INSULILN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 16, 2014

    EON RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 19, 2011

    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

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP

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

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

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

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017