10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
EMIT C-REACTIVE PROTEIN ASSAY
FDA 510(k)
FDA Class 2
·Immunology
Couture Essence
FDA UDI
Carolon Company·00078301881437·
Couture Essence
FDA UDI
Carolon Company·00078301821433·
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268214131·CUSTOM SURGICAL KIT VEIN ENDOVENOUS PACK
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
CROSSFIX II MEMISCAL REPAIR DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 25, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·November 6, 2012
BRILLIANCE ICT
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS (CLEVELAND)·Product code JAK·August 24, 2010
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024