10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COMBILINES HEMODIALYSIS BLOOD TUBING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LITHOGOLD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 18, 2015
STOPCOCK MANIFOLD GANGS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020
INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·February 14, 2013
SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MND·January 17, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 28, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 27, 2015
1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of the internal structures of the head or body. The images produced by the signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010