11 results
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19ms
·
Sources: EU EUDAMED, US FDA
SMALL BONE FIXATION SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450224427·
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327627640·2.9X15.5MM KNOTILUS+ ANCHOR - PEEK
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327627657·2.9X12.5MM KNOTILUS+ ANCHOR - PEEK
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327627664·2.9X12.5MM KNOTILUS+ HIP ANCHOR - PEEK
PSYCHEMEDICS CANNABINOIDS EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HANDPIECE SHEATH-MODEL #A910
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 1, 2010
XPRT MATTRESS W/O PENDANT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code IKZ·July 3, 2014
3) Signa Advantage (K911959 Signa Advantage 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