26 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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VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT
FDA 510(k)
FDA Unclassified
·Unknown
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103669·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103621·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103645·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103607·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103683·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103614·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103584·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103577·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103638·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103652·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103676·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103591·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304103560·
3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
FDA 510(k)
FDA Class 1
·General Hospital
RENAL UROLOGY STENT K072293
FDA Adverse Event
Other
·FOSSA MEDICAL INC·Product code FAD·April 10, 2014
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
BIOTENE
FDA Adverse Event
Injury
·ULTRADENT PRODUCTS INC/ORATECH LLC·Product code LFD·October 9, 2019
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013