7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANESTHESIA MACHINE, CHEMETRON
FDA 510(k)
FDA Class 2
·Anesthesiology
POYA 3.5mm Medial Proximal Tibia System
FDA 510(k)
FDA Class 2
·Orthopedic
ENPULSE SR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014
CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER
FDA Adverse Event
Malfunction
·J.T. POWEY COMPANY·Product code BSK·November 2, 2012
REPAIR CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·September 21, 2010
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