7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC
FDA 510(k)
FDA Class 1
·Anesthesiology
AS101, BLOOD PRESSURE CUFF
FDA 510(k)
FDA Class 2
·Cardiovascular
LANCER MB/CPK ISOENZYME KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VIRTUOSO
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 7, 2010
ENDURON 10D 56 OR 68ODX28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·December 6, 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