BEUDAMED
    111 results · 28ms · Sources: EU EUDAMED, US FDA

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    Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

    FDA Recall
    Terminated ·Braemar Manufacturing, LLC·Product code MWJ·January 22, 2020

    Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour Configuration - 453564067171 96-Hour Configuration - 453564067181 7-Day Configuration Model Number: 860322

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MWJ·January 13, 2020

    Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

    FDA Recall
    Terminated ·Braemar Manufacturing, LLC·Product code MWJ·January 22, 2020

    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code LQC·January 4, 2021

    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code LQC·January 4, 2021

    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·August 14, 2019

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·April 1, 2019

    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEM·June 10, 2019

    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

    Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDT·January 28, 2021

    Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code FDI·May 3, 2010

    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·July 24, 2019

    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022