24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PYRAMESH® C Titanium Mesh
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074471594·MESH-MACH-KIDNEY-10X32X9-4
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450293263·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450286746·
OSTEONICS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·March 9, 2012
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·August 16, 2017
5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·August 9, 2012
HOSPIRA PLUM A+ INFUSION
FDA Adverse Event
Malfunction
·HOSPIRA·Product code FRN·April 4, 2013
4 FR S/L GROSHONG NXT CLEARVUE
FDA Adverse Event
Injury
·C. R. BARD INC. (BASD)·Product code LJS·May 22, 2008
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 12, 2011
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·August 8, 2014
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code LPL·August 8, 2014
DAILTES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·December 6, 2012
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD.·Product code MVN·October 16, 2023
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·April 16, 2014
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·November 15, 2012
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·November 10, 2016