8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGICAL STAPLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123014·K-WIRE - SINGLE TROCAR 2.0mm DIA x 150mm
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Trident® Tritanium® PST® Acetabular Shells
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOSCOPIC INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 30, 2010
SYSTEM 5 SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·February 4, 2013
PRECISION SPECTRA®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 17, 2014
2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010