10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)
FDA 510(k)
FDA Class 2
·Cardiovascular
ZenFlex CM
FDA UDI
Kerr Corporation·00195062145490·.20/.04/25mm ZenFlex CM NiTi FILE REFILL PACK
ENVIRO SHARP SOLUTIONS 3
FDA 510(k)
FDA Class 2
·General Hospital
LITECURE THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·Product code OYC·October 18, 2014
COLLEAGUE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
T2 STRATOSPHERE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020
MIDAS REX MR8
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025
MOTOR MR8 ELECTRIC
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022