12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TOTAL PROTEIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022544·ASSY ORTHOS CM SGL 15UFM -10X22 UL
BABI*PLUS BUBBLE PAP VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
Zavation Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
L.C. 5000/CE NITROGL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 27, 2009
NITRO I.V. DC INF. SET W/LB TBG
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2011
L.C. 5000/CE NITROGLYCERIN PUM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 22, 2012
RIATA PASSIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 3, 2010
Y-ADAPT-PL-2.4 SHAFT 8HO HE 3HO L56 TI
FDA Adverse Event
Malfunction
·SYNTHES USA,·Product code HRS·December 29, 2012
OEC 9800 Systems with 9-inch Image Intensifier
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023
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