8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ECLIPSE TOTAL ANKLE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
PROTECTA XT DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·June 10, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·December 7, 2012
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
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012