10 results
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34ms
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Sources: EU EUDAMED, US FDA
THE AUTOLET LITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
FDA 510(k)
FDA Class 2
·Neurology
H.P.T. HOME PREG. TEST KIT & A.P.T.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·December 29, 2016
X-FLOW CATHETER
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·June 11, 2020
SYMBIQ SINGLE CHAN I
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS COSTA RICA LTD.·Product code FRN·April 25, 2014
HOMECHOICE, DOMESTIC 120V
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 9, 2010
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·December 27, 2012
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017