7 results
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20ms
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Sources: EU EUDAMED, US FDA
RAISED CHAIR W/FOOT PLATFORM
FDA 510(k)
FDA Class 1
·Physical Medicine
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
FDA 510(k)
FDA Class 2
·General Hospital
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
35 CM BIPOLAR LEAD
FDA Adverse Event
Death
·GREATBATCH MEDICAL·Product code DTB·May 6, 2014
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 31, 2012
SIGNA EXCITE 1.5T
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code LNH·August 16, 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