9 results
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26ms
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Sources: EU EUDAMED, US FDA
PROLENE POLYPROPYLENE LIGATING CLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AccuDiag ™
FDA UDI
Diagnostic Automation, Inc.·00894175000282·AccuDiag™ Fasciola IgG ELISA
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
REJUVENIQUE MODEL #RJV10
FDA 510(k)
FDA Class 2
·Neurology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 15, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC. USA·Product code LFR·November 5, 2007
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWP·October 31, 2012
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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