7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACE-DUPONT COMPOSITE RINGS
FDA 510(k)
FDA Class 2
·Orthopedic
COBE CENTRYSYSTEM 3 BICART OPTION KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LAPAROCOPIC MYOMA SCREW
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 11, 2013
ACCU-CHEK MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 10, 2011
XMAX MOTOR, HIGH STRENGTH HOSE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·December 13, 2013
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