8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single Use Hemoclips
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRECISION QID
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE·Product code NBW·October 19, 2005
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AlloX2 Pro Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 19, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 30, 2011
COYOTE? ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·July 18, 2013
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Enforcement
Class III
·Terminated·Invivo Corporation·October 28, 2020