15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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8-CH Electroencephalography Amplifier
FDA 510(k)
FDA Class 2
·Neurology
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446857723·SPECIAL, EXPRT REVISION HIP DISTAL STEM TRIAL, ...
HHM
FDA UDI
Oticon A/S·05707131351494·G500 SC, BTE PP 13 2.4G 105 C093 TAR HHM
CODMAN
FDA UDI
Cerenovus, Inc.·10886704001997·CODMAN SLIM-LINE Aneurysm Clip Reinforcing Angl...
DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·March 25, 2011
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·THE HEART VALVES, INC.·Product code LWR·October 10, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·July 2, 2013
BD CATHENA¿ SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 8, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 3, 2012
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021