8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TRIGLYCERIDE ENZYMATIC METHOD
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALIF
FDA UDI
Nuvasive, Inc.·00887517622013·ALIF Interfixated Screw, 6.0x27.5mm Var
ENDOSSEOUS DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BiopSee, Mobile US
FDA 510(k)
FDA Class 2
·Radiology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 24, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 27, 2007
LUGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code DQX·September 7, 2012
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