13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CoRoent
FDA UDI
Nuvasive, Inc.·00887517628220·CoRoent Ant TLIF Ti, 10x10x34mm 12°
INBONE
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420196347·Removal Screw Handle
Saw Blade
FDA UDI
Treace Medical Concepts, Inc.·00810111224536·FeatherRasp - L
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054813·METZENBAUM SCISSORS CURVED BLADES POWER CUT GOLD
UNIVERSAL NEURO 3
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327600971·Translabyrinthine plate small
UNIFIL FLOW
FDA 510(k)
FDA Class 2
·Dental
CO2 Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·December 27, 2016
ANEURX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
CYLOS DR-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code DXY·July 1, 2013
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