8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAPIOX LEVEL ALARM
FDA 510(k)
FDA Class 2
·Cardiovascular
STEINMAN PIN
FDA 510(k)
FDA Class 2
·Orthopedic
QUICKVUE AT-HOME OTC COVID-19 TEST
FDA Adverse Event
Malfunction
·QUIDEL CORPORATION·Product code QKP·February 10, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 22, 2013
VICTORY XL DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code LWP·January 15, 2014
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
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