7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
FDA 510(k)
FDA Class 2
·Immunology
AXIAL COMPRESSION SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
BELTBEAT WF-400
FDA 510(k)
FDA Class 2
·Cardiovascular
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·February 28, 2013
REFLECTION
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, INC.·Product code JDH·February 10, 2011
135 DEG DHS® PLATE-SHORT BARREL 4 HOLES/78MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code KTT·August 6, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024