7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATCH FABRIC
FDA 510(k)
FDA Class 2
·Cardiovascular
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
FDA 510(k)
FDA Class 2
·Physical Medicine
OLYMPUS CK-MB REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 24, 2014
ACCU-CHEK COMPACT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·November 12, 2007
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·October 3, 2012
NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog No. 60041161, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015