7 results
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36ms
·
Sources: EU EUDAMED, US FDA
PEGASUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DELUXE SANITARY PAD
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
NOVA 11 NA/K/LI ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONCERTO CRT-D DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·December 14, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 22, 2013
TOTAL ASR ACET IMP SIZE 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 10, 2014
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021