7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WHISPER SWIVEL II EXHALATION PORT
FDA 510(k)
FDA Class 2
·Anesthesiology
POGO Automatic Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TINA-QUANT D-DIMER TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 14, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 17, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 28, 2014
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021