8 results
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35ms
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Sources: EU EUDAMED, US FDA
MOISTURE TRAP
FDA 510(k)
FDA Class 1
·Anesthesiology
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DUAL EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 12, 2014
MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code KNW·October 29, 2007
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 6, 2012
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 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