7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REPROCESSED EXTERNAL FIXATION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
RADIUS NEXT GENERATION GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
FDA 510(k)
FDA Class 2
·Orthopedic
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 18, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2008
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015