8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ISOLATION GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Infra-red forehead thermometer
FDA 510(k)
FDA Class 2
·General Hospital
LoFric Elle Pro
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 7, 2018
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·May 23, 2014
VM8: MICROSTREAM CO2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 15, 2013
TAMPAX, SUPER PLUS UNSCENTED (NOT APPLICABLE) TAMPON 1APPLIC
FDA Adverse Event
Injury
·TAMBRANDS MANUFACTURING, INC.·Product code HEB·January 11, 2011
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