7 results
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21ms
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Sources: EU EUDAMED, US FDA
WAX CURETTE TIP
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
FDA 510(k)
FDA Class 2
·Neurology
PSA SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 21, 2014
IMPLANT PDS3000M 6PK PILLAR PALATAL
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code LRK·October 29, 2012
ULTRACISION HARMONIC SCALPEL HAND PIECE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·January 16, 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