7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
MILLAR PULSED DOPPLER VELOCIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
FDA 510(k)
FDA Class 2
·Cardiovascular
Ambu USR, Ambu M
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VIVA XT
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·December 6, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 22, 2015
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