10 results
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21ms
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Sources: EU EUDAMED, US FDA
OMNI DIAGNOST
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Richard Wolf GmbH·04055207044568·BASE SECTION FOR STANDARD TIBIAL graduated, mo...
TISSUE CULTURE REFEEDING MEDIUM
FDA 510(k)
FDA Class 1
·Hematology
DESERET SUBCLAVIAN JUGULAR CATHETER SET
FDA 510(k)
FDA Class 2
·General Hospital
HUMAPEN ERGO
FDA Adverse Event
Injury
·ELI LILLY AND COMPANY·Product code NSC·June 16, 2014
ACUITY
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·October 19, 2010
UNKNOWN DEPUY POLY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·December 14, 2012
PFNA-II BLADE L115 TAN
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·July 8, 2020
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