8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMASTIX REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Hematology
ORTHOKROME* HEPARIN
FDA 510(k)
FDA Class 2
·Hematology
CONCEPT INLAY/ONLAY
FDA 510(k)
FDA Class 2
·Dental
VERITY DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·January 9, 2013
ARTICUL/EZE BALL 28 +1.5 GR
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MED (DEPUY - SUZHOU) LTD·Product code JDI·November 19, 2010
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013
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