9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
CRIT-LINE MONITOR III (CLM III)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Temena
FDA UDI
Temena GmbH·03700339711550·Pencil point spinal needle 22/ 27G x 90 mm with...
MULTI-AD FLUID DISPENSING SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
FDA 510(k)
FDA Class 2
·Neurology
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 7, 2013
PRECISION XTRA
FDA Adverse Event
Injury
·Product code NBW·February 15, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
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