7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION
FDA 510(k)
FDA Class 1
·General Hospital
A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)
FDA 510(k)
FDA Class 2
·Dental
TKO TELESCOPING LITHOTOMY STIRRUP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·February 15, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 23, 2010
DERMABOND
FDA Adverse Event
Injury
·ETHICON INC.·Product code MPN·July 29, 2014
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016