8 results
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27ms
·
Sources: EU EUDAMED, US FDA
MICRO BI-POLAR FORCEPS #39-200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·Physical Medicine
Cerebrotech CMS-5000
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDEAVOR RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·November 28, 2013
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·April 24, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 3, 2012
ACCU-CHEK ADVANTAGE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·February 5, 2008
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