9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
FDA 510(k)
FDA Class 2
·Immunology
OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE
FDA 510(k)
FDA Class 2
·Dental
ARTIS pheno
FDA 510(k)
FDA Class 2
·Radiology
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code MBI·April 27, 2012
EMS SWISS LITHOCLAST LITHOTRIPTER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FFK·May 6, 2010
QUADROX
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DWE·June 18, 2014
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·February 12, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTORNIC CARDIOVASCULAR GALWAY·Product code NIQ·January 14, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024