9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIEMENS INTRAVAGINAL TRANSDUCER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403153051·Snowden-Pencer ENDOPLASTIC DISSECTOR CURVED, RO...
Buxton Biomedical
FDA UDI
Buxton Biomedical Inc·B7688850610·Luer SA Rongeur, 140mm,lite cv
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
CURITY PERCUTANEOUS CATHETER INSERTION KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 19, 2014
ACCU-CHEK MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 28, 2010
HEARTMATE II LVAS, EUROPE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·December 19, 2012
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017