BEUDAMED
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    B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code DYB·May 8, 2006

    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

    FDA Recall
    Terminated ·Alivecor SFO·Product code DXH·January 9, 2015

    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

    FDA Enforcement
    Class III ·Terminated·Alivecor SFO·February 25, 2015

    Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018

    STERIS 4085, 5085 & 5085SRT Surgical Tables

    FDA Recall
    Terminated ·Steris Corporation·Product code FQO·May 14, 2010

    The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.

    FDA Recall
    Terminated ·Steris Corporation·Product code FQO·June 27, 2014

    Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); distributed by Stryker Communications, Flower Mound, TX 75028. The 0682-000-414 (FP Shroud version 2 reworked) is a shroud designed to cover the cabling necessary on a Stryker Version 3 Monitor when mounted on the Flat Panel Arm.

    FDA Recall
    Terminated ·Stryker Communications Corp·Product code FQO·September 2, 2008

    Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.

    FDA Recall
    Terminated ·Maquet Medical Systems, Usa·Product code FQO·April 13, 2012

    Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FQO·September 30, 2013

    TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.

    FDA Recall
    Terminated ·Berchtold Corp.·Product code FQO·September 23, 2015

    Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FQO·June 10, 2015

    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·March 28, 2016

    IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018

    IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018

    Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.

    FDA Recall
    Terminated ·Helena Laboratories, Corp.·Product code GFO·January 5, 2021

    OR table TITAN U, Surgical Table. Surgical bed with Orthopedic Accessories.

    FDA Recall
    Terminated ·Trumpf Medical Systems, Inc.·Product code FQO·January 21, 2011

    Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·December 2, 2015

    IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·November 6, 2018

    IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·November 6, 2018

    Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S, 0788100001, and 0788100001S

    FDA Recall
    Terminated ·Stryker Communications Corp·Product code FQO·November 13, 2009