8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KARL STORZ INSULATED BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORNEOMAP 4500
FDA 510(k)
FDA Class 2
·Radiology
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERSACARE BED
FDA Adverse Event
HILL-ROM INC.·Product code FNL·January 31, 2013
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·December 6, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 18, 2014
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 17, 2012
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DQO·September 28, 2012