11 results
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25ms
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Sources: EU EUDAMED, US FDA
CEMENT-PICK
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Integra® Total Foot System
FDA UDI
Ascension Orthopedics, Inc.·10381780119104·The standard forefoot screw is used in the Inte...
Total Foot System 2
FDA UDI
Smith & Nephew, Inc.·00885556838716·2.2MM PLATE LAG SCREW 8MM
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788221080·Steerable IBD Trial 8x10x28, 6 deg
KEMTROL SERUM CONTROL-NORMAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 20, 2014
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 9, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·August 19, 2010
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 18, 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