75 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that integrates an AC power module and microscope controls (Primary Control Panel and connectivity of foot controllers)
FDA Enforcement
Class II
·Terminated·Alcon Research, Ltd.·September 2, 2015
Nebion H LX-8 magnetic resonance device and stand. Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion H LX-8
FDA Recall
Terminated
·Nebion, LLC·June 25, 2008
LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HRM·May 25, 2017
LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that integrates an AC power module and microscope controls (Primary Control Panel and connectivity of foot controllers)
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HRM·August 11, 2015
LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries
FDA Enforcement
Class II
·Terminated·Alcon Research, Ltd.·September 6, 2017
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·October 9, 2019
Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, K12-MIC09010, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, K12-MIC04505, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, K12-MIC04510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, K12-MIC13505, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, MIC5-135-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, MIC5-135-5-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, MIC5-90-20-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, MIC5-45-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, MIC5-45-20-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, MIC5-135-20-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, MIC5-45-10-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010
Mistique Infusion Catheter, MIC5-45-5-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010