8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209129195·
FILTRARE TM ALLVENT TM
FDA 510(k)
FDA Class 2
·General Hospital
MODEL 78210A TELEMETRY TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 6, 2014
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 3, 2012
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·September 29, 2010
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