BEUDAMED
    269 results · 14ms · Sources: EU EUDAMED, US FDA

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    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

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

    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

    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

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

    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

    ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·September 11, 2008

    ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code KOG·February 19, 2010

    The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.

    FDA Recall
    Terminated ·Custom Ultrasonics, Inc.·Product code NVE·May 6, 2016

    Flexible Intubation Fiberscope, Model # 11301AB1

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EOQ·April 24, 2019

    GE Healthcare OEC 9900 mobile fluoroscopic x-ray system

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·December 14, 2007

    The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.

    FDA Enforcement
    Class II ·Terminated·Custom Ultrasonics, Inc.·July 13, 2016

    DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.

    FDA Recall
    Terminated ·Minntech Corp·Product code FEB·June 15, 2010

    Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DER·May 16, 2018

    GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code FER·December 12, 2018

    Clinical Chemistry Apolipoprotein A1, List Number 9D92-20

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code DER·November 10, 2005

    Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

    FDA Recall
    Terminated ·Ferring Pharmaceuticals Inc·Product code MOZ·April 16, 2010

    GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·August 29, 2008

    OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·April 15, 2008

    GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·August 12, 2008

    GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·July 2, 2008

    OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·April 15, 2008