7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE
FDA 510(k)
FDA Class 2
·Anesthesiology
STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIED
FDA 510(k)
FDA Class 2
·General Hospital
PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
SYSMEX CA-1500 ANALYZER
FDA Adverse Event
Other
·SYSMEX CORPORATION·Product code GKP·June 27, 2014
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 30, 2013
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·December 3, 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