8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
HUMAC SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122772·K-WIRE - SINGLE TROCAR THREADED 2.0mm DIA x 230mm
SPLASH! IMPRESSION MATERIAL DEVICE
FDA 510(k)
FDA Class 2
·Dental
Reprocessed Steerable Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·January 4, 2011
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024