8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
FLOW-DIRECTED BALLOON THERMODILUTION
FDA 510(k)
FDA Class 3
·Cardiovascular
ERA® Implant Abutment Micro 0°, 1mm Cuff (AK)
FDA UDI
STERNGOLD DENTAL LLC·00841549104381·Implant retained overdentures are an establishe...
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
FDA 510(k)
FDA Class 2
·Dental
ZOLL PROPAQ MD
FDA 510(k)
FDA Class 3
·Cardiovascular
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 15, 2014
ATTAIN OTW
FDA Adverse Event
Malfunction
·MPRI·Product code LWP·October 31, 2012
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHLIPS MEDICAL SYSTEMS·Product code MHX·August 17, 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