9 results
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17ms
·
Sources: EU EUDAMED, US FDA
ELIAS TMAB
FDA 510(k)
FDA Class 2
·Immunology
NE-U07
FDA 510(k)
FDA Class 2
·Anesthesiology
TITANIUM VENTILATION TUBES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 22, 2013
ISOFLEX S
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
ABC HANDPIECE LAPAROSCOPIC
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025