8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent
FDA 510(k)
FDA Class 2
·Dental
CYNOSURE 1064NM DIODE LASER
FDA 510(k)
FDA Class 2
·Physical Medicine
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GMK-HINGE GMK-HINGE FEMORAL COMPONENT R - SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·July 28, 2020
CERVIC-DISTRACT R W/ADJUST-ANGLE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWB·June 17, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 24, 2011
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·October 1, 2014
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