10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NAGASHIMA SN AUTOMATIC TREATMENT CHAIR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788220130·10mm Right Handed Nerve Root Retractor
LUNGCARE CT SOFTWARE PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 4, 2012
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 29, 2015
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 20, 2014
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·October 1, 2012
CAPSURE EPI
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·September 1, 2010
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021