BEUDAMED
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    CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SleepWeaver Elan - Mask Only - Large - Beige

    FDA UDI
    CIRCADIANCE, LLC·B036100663·SleepWeaver Elan Cloth Nasal PAP Mask Only - La...

    NITANIUM® SUPER ELASTIC ARCHWIRES

    FDA UDI
    Ortho Organizers, Inc.·00190707059781·.016 X .022 LOWER NITANIUM® SUPER ELASTIC PRO F...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450388051·

    Indus®

    FDA UDI
    SPINEFRONTIER, INC.·00190361001348·Invue Max, Three Level ACP, 63mm

    Monoblock Tibial Trial PS Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215042660·

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494462177·Hook Probe Plastic Handle D 3.0mm, WL 310mm

    KRONNER LOW PROFILE SCOPE HOLDER

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

    POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    MEDEL S.P.A.·Product code BTI·May 8, 2013

    UNKNOWN DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·May 12, 2011

    HEPARIN LOCK-FLUSH 100 UNITS/ML

    FDA Adverse Event
    Injury ·HOSPIRA·Product code NZW·August 6, 2008

    COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿

    FDA Adverse Event
    Injury ·MEDTRONIC EUROPE SARL·Product code NIK·June 27, 2024

    Brilliance iCT Computed Tomography X-ray system, Model 728306

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    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 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

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    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

    IVEA Product Part Number 16100 Model 500A

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