12 results
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25ms
·
Sources: EU EUDAMED, US FDA
BALLOON WEDGE PRESSURE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788220340·12mm Lumbar Shaver Distractor
75H - Class A MRO 21 - w/Select Logo
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620343·75H - Class A MRO 21 - w/Select Logo
MRJ 3300
FDA 510(k)
FDA Class 2
·Radiology
RightLance Blood Lancing System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Malfunction
·COOK, INC.·Product code MIH·May 7, 2014
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 20, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 9, 2012
BIOSTEON INTERFERENCE SCREW
FDA Adverse Event
Malfunction
·BIOCOMPOSITES LTD.·Product code HWC·July 22, 2010
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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