7 results
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17ms
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Sources: EU EUDAMED, US FDA
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
VASCULAR CATHETER
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NEURO DIAGNOSTICS MODEL FCR
FDA 510(k)
FDA Class 2
·Neurology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 27, 2014
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·November 15, 2012
SINGLE 8 EXTENSION, 30 CM LENGTH
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·September 13, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018