29 results
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19ms
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Sources: EU EUDAMED, US FDA
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code OAE·September 21, 2018
TENDRIL ST
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·December 10, 2018
NEXGEN CR-FLEX GSF FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·May 14, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 6, 2012
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·August 24, 2010
SofTech Pressure-Sensing Wheelchair Cushions
FDA Recall
Open, Classified
·Aquila Corporation·Product code KNN·July 6, 2023
APK2 Pressure-Sensing Wheelchair Cushions
FDA Recall
Open, Classified
·Aquila Corporation·Product code KNN·July 6, 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