45 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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LightPod ERA lasers
FDA Enforcement
Class II
·Terminated·Aerolase Corporation·January 15, 2020
LightPod ERA lasers
FDA Recall
Terminated
·Aerolase Corporation·Product code GEX·August 1, 2019
Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified and reported. The products are marketed under names including FriendlyLight Er:YAG, LightPod Era, FriendlyLight Nd:YAG, LightPod Neo, LightPod Neo XL, LightPod Neo XT, LightPod Forte, LightPod Allure, and LightPod Nova.
FDA Recall
Terminated
·Aerolase·Product code GEX·June 7, 2011
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
FDA Recall
Terminated
·New Era Orthopaedics, LLc·Product code MNI·February 13, 2017
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
FDA Enforcement
Class II
·Terminated·New Era Orthopaedics, LLc·August 15, 2018
(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel and Navigation Arm. The Spring Arm that is subject to this field action suspends loads, is a conduit for power/data, and facilitates multi-directional movement. The Spring Arms that have been identified within scope are replacement parts that have potentially been serviced incorrectly.
FDA Enforcement
Class II
·Terminated·Stryker Communications, Inc.·January 16, 2013
MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·April 24, 2014
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·July 9, 2019
MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·June 20, 2011
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019
Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·January 26, 2012
Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·October 17, 2016
Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 19, 2017
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·April 13, 2016
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 11, 2016
All Med Medical 20ga x 1" RA Hub Needle Model #M201H Reorder #55-2030 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
FDA Recall
Terminated
·Multi-Med, Inc.·Product code FMI·August 30, 2010
All Med Medical 22ga x 1" RA Hub Needle Model #M221H Reorder #55-2230 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
FDA Recall
Terminated
·Multi-Med, Inc.·Product code FMI·August 30, 2010
All Med Medical 19ga x 1" RA Hub Needle Model #M191H Reorder #55-1930 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
FDA Recall
Terminated
·Multi-Med, Inc.·Product code FMI·August 30, 2010
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·March 9, 2015