10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
GENESIS 180
FDA 510(k)
FDA Class 2
·Radiology
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 9, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 9, 2024
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC
FDA 510(k)
FDA Class 3
·Cardiovascular
THEKEN ATOLL OCT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 11X360MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code JDS·October 11, 2012
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 13, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 23, 2010
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 15, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024