7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
STIMULAN- CALCIUM SULFATE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLOR LCD MONITOR
FDA 510(k)
FDA Class 2
·Radiology
TRELLIS 8 120X30
FDA Adverse Event
EV3 INC.·Product code KRA·February 28, 2013
EQUINOXE COMPRESSION SCREW/LOCKING CAP
FDA Adverse Event
Other
·EXACTECH, INC.·Product code HWC·July 25, 2014
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC·Product code LWR·February 1, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024