8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS CHLORIDE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N/A
FDA UDI
Tyber Medical, LLC·M695M9253380·
CONDUCTIVE SURGIGRIP SPIRAL SLEEVE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SIDE PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·January 22, 2013
ATTAIN STARFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·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