11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
IMPACTOR FOR FEMORAL HEAD
FDA 510(k)
FDA Class 1
·Orthopedic
FORZA
FDA UDI
Orthofix US LLC·18257200077106·MONOLITHIC CORNER TAMP
TRACH T W/DRAINAGE BAG
FDA 510(k)
FDA Class 1
·Anesthesiology
ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000
FDA 510(k)
FDA Class 2
·General Hospital
GIALLOY CB
FDA UDI
SRL Dental GmbH·ESRL58901561·Aufbrennfähige Nichtedelmetall-Dental-Gusslegie...
MONOCRYL PLUS SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·June 24, 2014
PROCEDURAL PACKS
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE·Product code HRX·November 3, 2010
PROMOTE RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·December 28, 2012
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·February 16, 2024
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·February 16, 2024
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012