8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
MEDICAL DIODE LASER SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTOMOBILE LIGHTER POWER CORD
FDA 510(k)
FDA Class 2
·Anesthesiology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWP·June 10, 2014
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·December 5, 2012
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 22, 2015
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
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