10 results
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24ms
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Sources: EU EUDAMED, US FDA
Lipocosm Harmonic System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Ophthalmic
Luggie Super
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
INTERBODY DEVICE
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code NEK·December 3, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·September 16, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 25, 2013
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 7, 2018
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 7, 2018
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024