12 results
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19ms
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Sources: EU EUDAMED, US FDA
A.C. SPLINT
FDA 510(k)
FDA Class 1
·Physical Medicine
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780519645·CODMAN® HAKIM® Precision Fixed Pressure Valve i...
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780534877·Precision Fixed Pressure Valve In-Line Valve an...
CODMAN HAKIM
FDA UDI
Cerenovus, Inc.·10886704041764·CODMAN HAKIM Precision Fixed Pressure Valve In-...
Obtura Spartan
FDA UDI
Young Innovations, Inc.·00843471100424·Obtura III Max Handpiece
MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
FDA 510(k)
FDA Class 2
·Dental
PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ST360 SET SCREW, FLAT, 1/4-28, PACKAGED
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code KWQ·October 29, 2012
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·February 20, 2014
REALIZE ADJ GASTRIC BAND-C
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·September 2, 2010
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