9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
2.5 MHZ PHASED ARRAY SECTOR MERIDIAN PROBE
FDA 510(k)
FDA Class 2
·Radiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209133376·
SERATEST ENA(RNP/SM) DETERMINATION
FDA 510(k)
FDA Class 2
·Immunology
PORCELAIN VENEER SYSTEM LABORATORY KIT
FDA 510(k)
FDA Class 2
·Dental
DA VINCI SURGICAL SYSTEM
FDA Adverse Event
Death
·INTUITIVE SURGICAL,INC.·Product code NAY·June 6, 2014
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·October 5, 2010
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 3, 2012
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025