9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
A-GENT LIQUID CALCIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981127398·18x15x5mm Rasp
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"
CAD/CAMouflage Milling Bock
FDA 510(k)
FDA Class 2
·Dental
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
FDA 510(k)
FDA Class 2
·Orthopedic
VIRTUOSO
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
TRIVEX SYSTEM VARICOSE VEIN TREATMENT
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.-ENDOSCOPY·Product code DWQ·October 1, 2010
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·November 5, 2012
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