BEUDAMED
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    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901107·PORTRAY System - Extraoral Source X-ray System

    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901114·PORTRAY System - Extraoral Source X-ray System

    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901022·Detector Holder, Anterior

    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901091·PORTRAY System - Extraoral Source X-ray System

    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901039·Detector Holder, Bite Wing

    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901046·Detector Holder, Posterior, LH

    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901077·X-Ray Detector

    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901060·Detector Holders Kit

    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901053·Detector Holder, Posterior, RH

    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901015·Coupler Ring w/ Magnets

    PORTRAY

    FDA UDI
    Surround Medical Systems·00850034901008·PORTRAY System - Extraoral Source X-ray System

    STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORP.·Product code LGW·April 6, 2009

    Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·December 20, 2023

    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland), Inc.·November 14, 2012

    NEBULIZERS TO DELIVER AEROSOLS

    FDA Adverse Event
    EMG TECHNOLOGY CO. LTD·Product code CAF·May 16, 2012

    VERCISE®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 8, 2014

    VERCISE GENUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·November 4, 2022

    AEQUALIS

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 31, 2018

    EON MINI

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS·Product code GZB·May 7, 2014