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Sources: EU EUDAMED, US FDA
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i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·August 29, 2012
Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 15, 2016
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·July 4, 2012
Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.
FDA Enforcement
Class II
·Terminated·Maytex Corp·June 12, 2013
i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code MMI·March 7, 2012
Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
FDA Recall
Terminated
·Vygon Corporation·Product code LJS·December 17, 2012
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
FDA Recall
Terminated
·Medtronic Vascular, Inc.·Product code MIH·September 19, 2012
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Recall
Terminated
·BioHorizons Implant Systems Inc·Product code DZE·November 19, 2012
The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.
FDA Recall
Terminated
·Kerr Corporation·Product code ELW·February 21, 2012
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Recall
Terminated
·BioHorizons Implant Systems Inc·Product code DZE·November 19, 2012
Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
FDA Recall
Terminated
·Trumpf Medical Systems, Inc.·Product code FSY·September 19, 2012
VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code KXK·January 25, 2012
MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13 Product Usage: Meditech Anatomical Pathology Software records, stores, codes, searches and provides reports for pathology cases. It enables pathology staff and other personnel to access related findings in real time.
FDA Recall
Terminated
·Medical Information Technology, Inc. Meditech Circle·Product code JQP·March 30, 2012
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.
FDA Recall
Terminated
·Impact Instrumentation, Inc.·Product code CBK·March 19, 2012
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 20, 2012
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·November 29, 2012
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code JJE·November 19, 2012