7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
FDA 510(k)
FDA Class 2
·Anesthesiology
MEKTOEN ENTERIC AGAR 100X15MM PLATE
FDA 510(k)
FDA Class 1
·Microbiology
Orion LifeSpan MEG
FDA 510(k)
FDA Class 2
·Neurology
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·March 6, 2013
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC INC.·Product code KRG·August 8, 2014
REVEAL XT
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·February 15, 2011
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021