17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POTENCY TEST STRIPS, INDICATOR TEST STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
FDA 510(k)
FDA Class 2
·Microbiology
PANOSOL II UVA-218
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code ETN·November 7, 2013
NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·June 3, 2015
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code ETN·December 16, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·February 22, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 1, 2014
NIM® 3.0 MAINFRAME
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015
ZONA PLUS
FDA Adverse Event
Injury
·ZONA HEALTH·Product code BXB·March 25, 2013
ENDOTRACH TUBE 8229507 CONTACT EMG 7MM
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·January 7, 2014
NIM® EMG ELECTRODE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GXZ·January 27, 2017
NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code ETN·July 1, 2016
NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·December 8, 2016
NIM® EMG ELECTRODE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GXZ·February 13, 2017
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