8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DISC NEEDLE SET #TX-8220
FDA 510(k)
FDA Class 1
·Dental
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APPLANATION TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·February 20, 2014
1G BLADED MAMMOTOME ST PROBE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code KNW·November 16, 2007
TRITON PUMP
FDA Adverse Event
Malfunction
·WALKMED INFUSION·Product code FRN·August 28, 2010
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 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