9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOCHECK IGE ELISA, MODEL BC-1035
FDA 510(k)
FDA Class 2
·Immunology
NONE
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code UNK·December 11, 2009
BIOMET FORERUNNER LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CO2 Laser Therapy System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TENOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·December 11, 2009
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 7, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·February 15, 2011
CONCERTO
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·August 8, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024