13 results
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18ms
·
Sources: EU EUDAMED, US FDA
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
FDA 510(k)
FDA Class 1
·Radiology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867439122·UNIVERS REVERS SIZE 4/33 STEM GUIDE PIN
PULLUP® Adjustable Juxtacortical Fixation Device
FDA 510(k)
FDA Class 2
·Orthopedic
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
FDA 510(k)
FDA Class 2
·Radiology
3.0MM CANNULATED SCREW LONG THREAD/34MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·February 19, 2013
ENDURANT II ILIAC STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·September 24, 2020
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 2, 2018
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·February 8, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 22, 2014
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 6, 2011
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 2, 2018
UNK-CV-SR
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 28, 2025
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017