8 results
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18ms
·
Sources: EU EUDAMED, US FDA
ARTHRITIC HEAT WRAP
FDA 510(k)
FDA Class 2
·Physical Medicine
NEUROSEARCH-24 OR NRS-24
FDA 510(k)
FDA Class 2
·Neurology
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PLUM LC OL CNVRTBL P
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 8, 2010
RIATA PASSIVE FIXATION
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 22, 2013
QUICKSITE XL LV
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 10, 2014
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024