12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAREFUSION NICOLET EDX
FDA 510(k)
FDA Class 2
·Neurology
AccessPLUS™
FDA UDI
Merit Medical Systems, Inc.·00884450699317·
NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 30, 2026
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 25, 2022
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013
SHER-I-BRONCH
FDA Adverse Event
TELEFLEX MEDICAL·Product code BTS·September 5, 2014
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIO·June 13, 2011
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 27, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 27, 2017
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023