9 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)
FDA 510(k)
FDA Class 2
·Radiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122796·K-WIRE - SINGLE TROCAR THREADED 2.8mm DIA x 230mm
DILATING TIP TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER
FDA Adverse Event
Injury
·Product code GCJ·June 20, 2006
SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55
FDA 510(k)
FDA Class 1
·General Hospital
da Vinci Xi Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDTRONIC.SIGMA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO·Product code NVZ·February 9, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·January 7, 2011
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·July 23, 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