9 results
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21ms
·
Sources: EU EUDAMED, US FDA
AMP 80/2 OUTFLOW MONITOR MODIFICATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARAGON INFUSION SYSTEM WITH BOLUS
FDA 510(k)
FDA Class 2
·General Hospital
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·May 21, 2014
IMPLANT PDS3000M 6PK PILLAR PALATAL
FDA Adverse Event
Injury
·XOMED MFG JACKSONVILLE·Product code LRK·October 29, 2012
STERLING ES PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·September 2, 2010
STEALTHSTATION TRIA NAVIGATION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 8, 2017
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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