BEUDAMED
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    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·June 4, 2014

    Stryker brand Neptune waste management system; model 711-27-1.

    FDA Recall
    Terminated ·Stryker Instruments, Instruments Div.·Product code FYD·December 3, 2002

    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 26, 2016

    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·April 17, 2013

    OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·February 23, 2022

    IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·June 6, 2011

    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·April 30, 2014

    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEB·June 23, 2016

    McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228

    FDA Recall
    Terminated ·Medical Action Industries Inc·Product code OVN·June 12, 2014

    O.R. TOWELS 25/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code KKX·July 10, 2015

    Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case; Manufactured for Medline Inductries, Inc., Mundelien, IL 60060 U.S.A., Made in China

    FDA Recall
    Terminated ·Medline Industries, Inc.·Product code LRO·March 30, 2006

    Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486

    FDA Recall
    Terminated ·Medline Industries Inc·Product code KKX·October 7, 2003

    McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228

    FDA Enforcement
    Class II ·Terminated·Medical Action Industries Inc·July 9, 2014

    Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MUJ·November 6, 2009

    O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code KKX·October 8, 2014

    OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEB·December 13, 2021

    Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.

    FDA Recall
    Terminated ·Steris Corporation·Product code FTD·February 23, 2010

    Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.

    FDA Recall
    Terminated ·Steris Corporation·Product code FTD·February 23, 2010

    Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.

    FDA Recall
    Terminated ·Steris Corporation·Product code FTD·February 23, 2010