9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
FDA 510(k)
FDA Class 2
·Orthopedic
U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
FDA 510(k)
FDA Class 2
·General Hospital
PICA WHOLE-BODY MRI SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SINGLE LUMEN 1.4FR POLYURETHANE PIC CATHETER
FDA Adverse Event
Injury
·FOOTPRINT MEDICAL INC.·Product code LJS·January 21, 2020
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 6, 2013
*
FDA Adverse Event
BOSTON SCIENTIFIC·Product code MND·July 12, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014
TASUKI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 6, 2019
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020