15 results
·
28ms
·
Sources: EU EUDAMED, US FDA
IV ALERT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PressON™
FDA UDI
NEXUS SPINE, L.L.C.·B6788202000·Removal Drill
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971093·
T7
FDA UDI
STRYKER CORPORATION·07613327466034·Zippered Toga
SPOTCHECK
FDA UDI
ASTORIA-PACIFIC, INC.·00725609000472·MS/MS Positive 1 Control Card
UniTip Catheter
FDA UDI
Unisensor AG·07640172971659·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972274·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971642·
Paltop Conical Implant System
FDA 510(k)
FDA Class 2
·Dental
PLAYTEX DEODORANT TAMPONS, MODEL 34802
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ATTELLICA ACETAMINOPHEN
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LDP·March 1, 2024
EVOLVE
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH, INC.·Product code IKY·April 1, 2014
PRUITT F3
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC·Product code FPA·October 15, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 4, 2015
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