7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TARGET MYOGLOBIN TEST
FDA 510(k)
FDA Class 2
·Immunology
SHARPOINT PDO (POLYDIOXANONE) SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
FDA 510(k)
FDA Class 2
·Dental
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 15, 2013
LANDMARX ELEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 21, 2010
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 29, 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